Lena Leissner - Academia.edu (original) (raw)
Papers by Lena Leissner
BMC pediatrics, Jan 23, 2017
The extensive vaccination programme against swine flu resulted in an increased incidence of narco... more The extensive vaccination programme against swine flu resulted in an increased incidence of narcolepsy among children and adolescents. There is a need to explore if these young persons' experiences have affected their trust in healthcare, their willingness to participate in future prevention programmes, and their contacts with the healthcare system. The overall aim is to identify factors important for the life-situation of children and adolescents with narcolepsy and their families, and factors that correlate with trust in healthcare. Data will be collected via questionnaires from all available children with narcolepsy following the vaccination and their families, as well as a control group of children with diabetes and their families. Longitudinal descriptive interviews will also be conducted with a selection of 20-25 children and their families. Techniques from media research will be used for Internet-based data collection and analysis of information relating to narcolepsy fro...
Sleep medicine reviews, Jan 10, 2014
Workers often attribute poor sleep to factors at work. Despite the large number of workers with s... more Workers often attribute poor sleep to factors at work. Despite the large number of workers with sleep disturbances, there is a lack of consensus on the relationship between the work environment and sleep. The purpose of this systematic review therefore was to conduct a comprehensive evaluation. To this end, we employed standardized methods to systematically locate, review, and tabulate the results of prospective or randomized studies of the impact of work factors on sleep disturbances. From the 7981 articles located in five databases, 24 fulfilled our inclusion criteria and formed the base of the review including meta-analyses of the effect sizes. Results showed that the psychosocial work variables of social support at work, control, and organizational justice were related to fewer sleep disturbances, while high work demands, job strain, bullying, and effort-reward imbalance were related to more future sleep disturbances. Moreover, working a steady shift was associated with disturba...
Regional anesthesia
The existence of differential sensory block during epidural analgesia has been confirmed by some ... more The existence of differential sensory block during epidural analgesia has been confirmed by some authors and disputed by others. This study attempts to elucidate this issue by using quantitative methods for evaluation of sensory block. A single epidural injection of 20 mL 0.5% bupivacaine with epinephrine was administered at the L1-T12 level in 11 male volunteers. Sensory block was evaluated by two qualitative (pinprick and light touch) and two quantitative methods (thermal stimulation with Thermotest [Somedic, Stockholm, Sweden] and argon laser stimulation). For measurement of motor block in the lower extremities and in the rectus abdominis muscle, quantitative methods were used. Sensory block was also assessed by somatosensory evoked potentials recorded during electrical and laser stimulation at the most cranial analgesic dermatome (loss of sharpness in pinprick perception) and the anesthetic dermatome L2 (loss of light touch perception). The zone of anesthesia was smaller than the zone of any other investigated variable. The cranial spread of analgesia and motor block was lower than that of laser-assessed block. Partial block of laser perception and thermal perception lasted longer than analgesia and motor block. No consistent segmental or temporal differences were found between the Thermotest and laser methods. During epidural block, prolongation of latencies and reduction in amplitudes of somatosensory evoked potentials produced at the most cranial analgesic dermatome did not differ significantly from those produced at the anesthetic dermatome. No differential block of small nerve fibers was found during epidural analgesia by Thermotest and argon laser stimulation. Recording of somatosensory evoked potentials did not demonstrate significant difference between responses from the sites with most superficial and with most intense sensory block.
Sleep & breathing = Schlaf & Atmung, 2015
This 10-year follow-up prospective study aimed to evaluate the effects of treatment with a mandib... more This 10-year follow-up prospective study aimed to evaluate the effects of treatment with a mandibular protruding device (MPD) on respiratory parameters and subjective symptoms in patients with obstructive sleep apnea (OSA) or snoring. Seventy-seven consecutive patients diagnosed with OSA or snoring were treated with an MPD. At baseline and the 10-year follow-up, a polygraphic examination and questionnaires on sleep quality were administrated and weight, and neck size was measured. At the 10-year follow-up, we examined 64 of the 77 patients and recorded their current treatment (45 MPD, 9 continuous positive airway pressure (CPAP), and 10 no treatment). For MPD patients, 89 % reported MPD use every night and 9 % several nights a week. Compared to baseline, MPD users with OSA had a significantly decreased oxygen desaturation index (ODI) (p = 0.006) and increased lowest arterial oxygen saturation, SaO2 nadir (p = 0.007) after 10 years. MPD treatment was successful for 70 % of OSA patien...
Regional anesthesia
The existence of differential sensory block during epidural analgesia has been confirmed by some ... more The existence of differential sensory block during epidural analgesia has been confirmed by some authors and disputed by others. This study attempts to elucidate this issue by using quantitative methods for evaluation of sensory block. A single epidural injection of 20 mL 0.5% bupivacaine with epinephrine was administered at the L1-T12 level in 11 male volunteers. Sensory block was evaluated by two qualitative (pinprick and light touch) and two quantitative methods (thermal stimulation with Thermotest [Somedic, Stockholm, Sweden] and argon laser stimulation). For measurement of motor block in the lower extremities and in the rectus abdominis muscle, quantitative methods were used. Sensory block was also assessed by somatosensory evoked potentials recorded during electrical and laser stimulation at the most cranial analgesic dermatome (loss of sharpness in pinprick perception) and the anesthetic dermatome L2 (loss of light touch perception). The zone of anesthesia was smaller than th...
Sleep medicine reviews, Jan 10, 2014
Workers often attribute poor sleep to factors at work. Despite the large number of workers with s... more Workers often attribute poor sleep to factors at work. Despite the large number of workers with sleep disturbances, there is a lack of consensus on the relationship between the work environment and sleep. The purpose of this systematic review therefore was to conduct a comprehensive evaluation. To this end, we employed standardized methods to systematically locate, review, and tabulate the results of prospective or randomized studies of the impact of work factors on sleep disturbances. From the 7981 articles located in five databases, 24 fulfilled our inclusion criteria and formed the base of the review including meta-analyses of the effect sizes. Results showed that the psychosocial work variables of social support at work, control, and organizational justice were related to fewer sleep disturbances, while high work demands, job strain, bullying, and effort-reward imbalance were related to more future sleep disturbances. Moreover, working a steady shift was associated with disturba...
Acta Paediatrica, 2014
According to a number of small case series, orthodontic treatment may have anti-enuretic effects.... more According to a number of small case series, orthodontic treatment may have anti-enuretic effects. Thus, we evaluated whether widening of the palate can alleviate enuresis and whether prognostic information can be gained from examining children's nocturnal respiration and nasal airway dimensions. Children with therapy-resistant enuresis underwent polysomnography, focusing on nocturnal respiration, and had their nasal airways examined. Rapid maxillary expansion was performed, widening the maxilla by approximately 0.5 cm. The dental appliance was removed after 6 months. Enuresis frequency was evaluated four times: at baseline, with the orthodontic apparatus in situ, after completed maxillary expansion and 1 year post-treatment. Of the 34 children recruited, one dropped out due to oral discomfort. The numbers of wet nights per week on the four assessment occasions were 5.48 ± 1.48, 5.12 ± 1.73, 3.09 ± 2.49 and 2.63 ± 2.81; p < 0.001. The proportions of responders, intermediate responders and non-responders during treatment were 21.2%, 27.3% and 51.5%, respectively. Responders were found to have a lower enuresis frequency at baseline (p = 0.001) and to have larger nasal airway dimensions (p = 0.01). Orthodontic widening of the palate may be curative in a subgroup of children with therapy-resistant enuresis.
Sleep Medicine, 2005
Background and Purpose: To estimate prevalence and severity (using the International Restless Leg... more Background and Purpose: To estimate prevalence and severity (using the International Restless Legs Syndrome Study Group Rating Scale (IRLS)) and to identify risk factors of restless legs syndrome (RLS). Patients and Methods: Population-based cross-sectional study; 2005 randomly selected adults 18 years and above participated in a telephone interview in Norway and Denmark, employing the next-birthday technique. Results: Of the cross-section, 11.5% fulfilled the diagnostic criteria for RLS. Half of these reported the symptoms as moderate to very severe. Mean duration of the complaint was 10 years. Prevalence was higher in females than in males (13.4 vs 9.4%) and lowest in the youngest age group (18-29 years, 6.3%). From 30 years and above, no clear age-related difference was seen. Main predictors of RLS were insomnia (odds ratios: 1.71-3.16) and symptoms of periodic limb movements in sleep (3.20-7.85). The response rate was 47%, making the results less reliable. Conclusions: This study indicates that there is a high occurrence of RLS among adults. Main predictors are insomnia and periodic limb movements in sleep. q
Sleep Medicine, 2007
Background: Restless legs syndrome (RLS) is a neurological movement disorder, which often causes ... more Background: Restless legs syndrome (RLS) is a neurological movement disorder, which often causes sleep problems. However, the comorbidity of this disorder is not well known. This study aimed to document the prevalence of RLS in the general population of Sweden and to identify factors associated with this condition. Methods: A cross-sectional study was performed in Sweden. One thousand subjects aged 18-90 years old underwent telephone interviews. The questionnaire assessed such factors as sleep variables, depressive mood, treatment of diabetes mellitus, and treatment with drugs for depression during the previous four-week period. RLS was diagnosed based on the minimal criteria provided by the International RLS Study Group. Results: The prevalence of RLS was 5% (5.7% in women, 3.5% in men). Severe or very severe RLS symptoms during the previous week were noted by 64% of the RLS subjects. Factors associated with RLS were insomnia, excessive daytime sleepiness, periodic limb movements in sleep, and depressed mood. Those affected by RLS were not more often consumers of drugs for depression than non-RLS subjects. Conclusions: RLS is prevalent in the general population in Sweden. RLS negatively influenced sleep and was associated with depressed mood. Antidepressive drug treatment was not associated with RLS.
Sleep And Breathing, 2001
The study objectives were to describe the changes in signs and symptoms of obstructive sleep apne... more The study objectives were to describe the changes in signs and symptoms of obstructive sleep apnea (OSA) and snoring using a mandibular protruding device (MPD) and to define the group of responders. The design of the study was a nonrandomized, open-labeled, prospective clinical study with a duration of 6 months. The setting was a hospital sleep laboratory and an ear, nose, and throat and dental outpatient clinic. Patients included 35 individuals treated: 22 with a diagnosis of OSA and 13 who snored without apnea.
Sleep Medicine, 2002
Background: Approximately 50% of our patients with sleep disturbances have periodic limb movement... more Background: Approximately 50% of our patients with sleep disturbances have periodic limb movements in sleep (PLMS). We have found that a high PLMS index is not correlated with the severity of symptoms on the Epworth Sleepiness Scale or response to pharmacologic therapy for restless legs syndrome (RLS)/PLMS. We hypothesized that differences in rhythm of contraction, predominance of periodic leg movements
Movement Disorders, 2007
We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 wee... more We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n ϭ 115) or pramipexole (n ϭ 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions-Improvement (CGI-I) assessments of "much/very much improved" (CGI-I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (ϮSE) in IRLS score were 5.7 (Ϯ0.9) for placebo (median dose 0.47 mg/day) and 12.3 (Ϯ0.6) for pramipexole (median dose 0.35 mg/day; P Ͻ 0.0001). CGI-I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P Ͻ 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study.
Sleep And Breathing, 2003
Objectives: To evaluate subjective discomfort and somnographic measures of patients with obstruct... more Objectives: To evaluate subjective discomfort and somnographic measures of patients with obstructive sleep apnea and snoring problems who had been treated for 2 years with a mandibular protruding device (MPD). Methods: The study population comprised 65 patients with a pretreatment diagnosis of obstructive sleep apnea (OSA) (n = 44) or habitual snoring without apnea (n = 21). After a baseline medical and somnographic examination, a functional examination of the stomatognathic system, and a questionnaire focused on sleep-related qualities, each patient received an MPD. Two follow-ups were made 6 months and 2 years after MPD treatment had been initiated, and all initial examinations were repeated. Results: At the 2-year follow-up, significant subjective improvements were registered in 90% of the patients regarding a reduction of snoring and apneas, in 76% regarding a reduction in daytime tiredness, and in 84% regarding an improvement in the quality of the night sleep (change of Ն 50% from baseline data). At the 2-year follow-up of the OSA group, the oxygen desaturation index (ODI) had dropped significantly from a mean value of 14.7 (SD, 12.7) to 3.1 (SD, 4.2) (P < 0.001), and the mean SaO 2 nadir rose from 78.2% (SD, 8.1) to 89.0% (SD, 4.7) (P < 0.001). Only one of the snorers increased his ODI value;
BMC pediatrics, Jan 23, 2017
The extensive vaccination programme against swine flu resulted in an increased incidence of narco... more The extensive vaccination programme against swine flu resulted in an increased incidence of narcolepsy among children and adolescents. There is a need to explore if these young persons' experiences have affected their trust in healthcare, their willingness to participate in future prevention programmes, and their contacts with the healthcare system. The overall aim is to identify factors important for the life-situation of children and adolescents with narcolepsy and their families, and factors that correlate with trust in healthcare. Data will be collected via questionnaires from all available children with narcolepsy following the vaccination and their families, as well as a control group of children with diabetes and their families. Longitudinal descriptive interviews will also be conducted with a selection of 20-25 children and their families. Techniques from media research will be used for Internet-based data collection and analysis of information relating to narcolepsy fro...
Sleep medicine reviews, Jan 10, 2014
Workers often attribute poor sleep to factors at work. Despite the large number of workers with s... more Workers often attribute poor sleep to factors at work. Despite the large number of workers with sleep disturbances, there is a lack of consensus on the relationship between the work environment and sleep. The purpose of this systematic review therefore was to conduct a comprehensive evaluation. To this end, we employed standardized methods to systematically locate, review, and tabulate the results of prospective or randomized studies of the impact of work factors on sleep disturbances. From the 7981 articles located in five databases, 24 fulfilled our inclusion criteria and formed the base of the review including meta-analyses of the effect sizes. Results showed that the psychosocial work variables of social support at work, control, and organizational justice were related to fewer sleep disturbances, while high work demands, job strain, bullying, and effort-reward imbalance were related to more future sleep disturbances. Moreover, working a steady shift was associated with disturba...
Regional anesthesia
The existence of differential sensory block during epidural analgesia has been confirmed by some ... more The existence of differential sensory block during epidural analgesia has been confirmed by some authors and disputed by others. This study attempts to elucidate this issue by using quantitative methods for evaluation of sensory block. A single epidural injection of 20 mL 0.5% bupivacaine with epinephrine was administered at the L1-T12 level in 11 male volunteers. Sensory block was evaluated by two qualitative (pinprick and light touch) and two quantitative methods (thermal stimulation with Thermotest [Somedic, Stockholm, Sweden] and argon laser stimulation). For measurement of motor block in the lower extremities and in the rectus abdominis muscle, quantitative methods were used. Sensory block was also assessed by somatosensory evoked potentials recorded during electrical and laser stimulation at the most cranial analgesic dermatome (loss of sharpness in pinprick perception) and the anesthetic dermatome L2 (loss of light touch perception). The zone of anesthesia was smaller than the zone of any other investigated variable. The cranial spread of analgesia and motor block was lower than that of laser-assessed block. Partial block of laser perception and thermal perception lasted longer than analgesia and motor block. No consistent segmental or temporal differences were found between the Thermotest and laser methods. During epidural block, prolongation of latencies and reduction in amplitudes of somatosensory evoked potentials produced at the most cranial analgesic dermatome did not differ significantly from those produced at the anesthetic dermatome. No differential block of small nerve fibers was found during epidural analgesia by Thermotest and argon laser stimulation. Recording of somatosensory evoked potentials did not demonstrate significant difference between responses from the sites with most superficial and with most intense sensory block.
Sleep & breathing = Schlaf & Atmung, 2015
This 10-year follow-up prospective study aimed to evaluate the effects of treatment with a mandib... more This 10-year follow-up prospective study aimed to evaluate the effects of treatment with a mandibular protruding device (MPD) on respiratory parameters and subjective symptoms in patients with obstructive sleep apnea (OSA) or snoring. Seventy-seven consecutive patients diagnosed with OSA or snoring were treated with an MPD. At baseline and the 10-year follow-up, a polygraphic examination and questionnaires on sleep quality were administrated and weight, and neck size was measured. At the 10-year follow-up, we examined 64 of the 77 patients and recorded their current treatment (45 MPD, 9 continuous positive airway pressure (CPAP), and 10 no treatment). For MPD patients, 89 % reported MPD use every night and 9 % several nights a week. Compared to baseline, MPD users with OSA had a significantly decreased oxygen desaturation index (ODI) (p = 0.006) and increased lowest arterial oxygen saturation, SaO2 nadir (p = 0.007) after 10 years. MPD treatment was successful for 70 % of OSA patien...
Regional anesthesia
The existence of differential sensory block during epidural analgesia has been confirmed by some ... more The existence of differential sensory block during epidural analgesia has been confirmed by some authors and disputed by others. This study attempts to elucidate this issue by using quantitative methods for evaluation of sensory block. A single epidural injection of 20 mL 0.5% bupivacaine with epinephrine was administered at the L1-T12 level in 11 male volunteers. Sensory block was evaluated by two qualitative (pinprick and light touch) and two quantitative methods (thermal stimulation with Thermotest [Somedic, Stockholm, Sweden] and argon laser stimulation). For measurement of motor block in the lower extremities and in the rectus abdominis muscle, quantitative methods were used. Sensory block was also assessed by somatosensory evoked potentials recorded during electrical and laser stimulation at the most cranial analgesic dermatome (loss of sharpness in pinprick perception) and the anesthetic dermatome L2 (loss of light touch perception). The zone of anesthesia was smaller than th...
Sleep medicine reviews, Jan 10, 2014
Workers often attribute poor sleep to factors at work. Despite the large number of workers with s... more Workers often attribute poor sleep to factors at work. Despite the large number of workers with sleep disturbances, there is a lack of consensus on the relationship between the work environment and sleep. The purpose of this systematic review therefore was to conduct a comprehensive evaluation. To this end, we employed standardized methods to systematically locate, review, and tabulate the results of prospective or randomized studies of the impact of work factors on sleep disturbances. From the 7981 articles located in five databases, 24 fulfilled our inclusion criteria and formed the base of the review including meta-analyses of the effect sizes. Results showed that the psychosocial work variables of social support at work, control, and organizational justice were related to fewer sleep disturbances, while high work demands, job strain, bullying, and effort-reward imbalance were related to more future sleep disturbances. Moreover, working a steady shift was associated with disturba...
Acta Paediatrica, 2014
According to a number of small case series, orthodontic treatment may have anti-enuretic effects.... more According to a number of small case series, orthodontic treatment may have anti-enuretic effects. Thus, we evaluated whether widening of the palate can alleviate enuresis and whether prognostic information can be gained from examining children&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s nocturnal respiration and nasal airway dimensions. Children with therapy-resistant enuresis underwent polysomnography, focusing on nocturnal respiration, and had their nasal airways examined. Rapid maxillary expansion was performed, widening the maxilla by approximately 0.5 cm. The dental appliance was removed after 6 months. Enuresis frequency was evaluated four times: at baseline, with the orthodontic apparatus in situ, after completed maxillary expansion and 1 year post-treatment. Of the 34 children recruited, one dropped out due to oral discomfort. The numbers of wet nights per week on the four assessment occasions were 5.48 ± 1.48, 5.12 ± 1.73, 3.09 ± 2.49 and 2.63 ± 2.81; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001. The proportions of responders, intermediate responders and non-responders during treatment were 21.2%, 27.3% and 51.5%, respectively. Responders were found to have a lower enuresis frequency at baseline (p = 0.001) and to have larger nasal airway dimensions (p = 0.01). Orthodontic widening of the palate may be curative in a subgroup of children with therapy-resistant enuresis.
Sleep Medicine, 2005
Background and Purpose: To estimate prevalence and severity (using the International Restless Leg... more Background and Purpose: To estimate prevalence and severity (using the International Restless Legs Syndrome Study Group Rating Scale (IRLS)) and to identify risk factors of restless legs syndrome (RLS). Patients and Methods: Population-based cross-sectional study; 2005 randomly selected adults 18 years and above participated in a telephone interview in Norway and Denmark, employing the next-birthday technique. Results: Of the cross-section, 11.5% fulfilled the diagnostic criteria for RLS. Half of these reported the symptoms as moderate to very severe. Mean duration of the complaint was 10 years. Prevalence was higher in females than in males (13.4 vs 9.4%) and lowest in the youngest age group (18-29 years, 6.3%). From 30 years and above, no clear age-related difference was seen. Main predictors of RLS were insomnia (odds ratios: 1.71-3.16) and symptoms of periodic limb movements in sleep (3.20-7.85). The response rate was 47%, making the results less reliable. Conclusions: This study indicates that there is a high occurrence of RLS among adults. Main predictors are insomnia and periodic limb movements in sleep. q
Sleep Medicine, 2007
Background: Restless legs syndrome (RLS) is a neurological movement disorder, which often causes ... more Background: Restless legs syndrome (RLS) is a neurological movement disorder, which often causes sleep problems. However, the comorbidity of this disorder is not well known. This study aimed to document the prevalence of RLS in the general population of Sweden and to identify factors associated with this condition. Methods: A cross-sectional study was performed in Sweden. One thousand subjects aged 18-90 years old underwent telephone interviews. The questionnaire assessed such factors as sleep variables, depressive mood, treatment of diabetes mellitus, and treatment with drugs for depression during the previous four-week period. RLS was diagnosed based on the minimal criteria provided by the International RLS Study Group. Results: The prevalence of RLS was 5% (5.7% in women, 3.5% in men). Severe or very severe RLS symptoms during the previous week were noted by 64% of the RLS subjects. Factors associated with RLS were insomnia, excessive daytime sleepiness, periodic limb movements in sleep, and depressed mood. Those affected by RLS were not more often consumers of drugs for depression than non-RLS subjects. Conclusions: RLS is prevalent in the general population in Sweden. RLS negatively influenced sleep and was associated with depressed mood. Antidepressive drug treatment was not associated with RLS.
Sleep And Breathing, 2001
The study objectives were to describe the changes in signs and symptoms of obstructive sleep apne... more The study objectives were to describe the changes in signs and symptoms of obstructive sleep apnea (OSA) and snoring using a mandibular protruding device (MPD) and to define the group of responders. The design of the study was a nonrandomized, open-labeled, prospective clinical study with a duration of 6 months. The setting was a hospital sleep laboratory and an ear, nose, and throat and dental outpatient clinic. Patients included 35 individuals treated: 22 with a diagnosis of OSA and 13 who snored without apnea.
Sleep Medicine, 2002
Background: Approximately 50% of our patients with sleep disturbances have periodic limb movement... more Background: Approximately 50% of our patients with sleep disturbances have periodic limb movements in sleep (PLMS). We have found that a high PLMS index is not correlated with the severity of symptoms on the Epworth Sleepiness Scale or response to pharmacologic therapy for restless legs syndrome (RLS)/PLMS. We hypothesized that differences in rhythm of contraction, predominance of periodic leg movements
Movement Disorders, 2007
We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 wee... more We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n ϭ 115) or pramipexole (n ϭ 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions-Improvement (CGI-I) assessments of "much/very much improved" (CGI-I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (ϮSE) in IRLS score were 5.7 (Ϯ0.9) for placebo (median dose 0.47 mg/day) and 12.3 (Ϯ0.6) for pramipexole (median dose 0.35 mg/day; P Ͻ 0.0001). CGI-I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P Ͻ 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study.
Sleep And Breathing, 2003
Objectives: To evaluate subjective discomfort and somnographic measures of patients with obstruct... more Objectives: To evaluate subjective discomfort and somnographic measures of patients with obstructive sleep apnea and snoring problems who had been treated for 2 years with a mandibular protruding device (MPD). Methods: The study population comprised 65 patients with a pretreatment diagnosis of obstructive sleep apnea (OSA) (n = 44) or habitual snoring without apnea (n = 21). After a baseline medical and somnographic examination, a functional examination of the stomatognathic system, and a questionnaire focused on sleep-related qualities, each patient received an MPD. Two follow-ups were made 6 months and 2 years after MPD treatment had been initiated, and all initial examinations were repeated. Results: At the 2-year follow-up, significant subjective improvements were registered in 90% of the patients regarding a reduction of snoring and apneas, in 76% regarding a reduction in daytime tiredness, and in 84% regarding an improvement in the quality of the night sleep (change of Ն 50% from baseline data). At the 2-year follow-up of the OSA group, the oxygen desaturation index (ODI) had dropped significantly from a mean value of 14.7 (SD, 12.7) to 3.1 (SD, 4.2) (P < 0.001), and the mean SaO 2 nadir rose from 78.2% (SD, 8.1) to 89.0% (SD, 4.7) (P < 0.001). Only one of the snorers increased his ODI value;