Clinical Trials
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Sleep Medicine
Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
Mar 2013In the near future more than 20% of the European population will be over 65 years old and the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly has scarcely been observed. The aim of this study is to investigate cognitive performance in elderly OSA patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (CPAP) treatment.
Impact of CPAP Therapy in Obstructive Sleep Apnea on Parameters of Nocturnal Pulse Wave Analysis
Mar 2013The present study aims to document and assess changes in single parameters of pulse wave analysis (ASI single parameters) as well as to evaluate ASI cardiovascular risk assessment before initiation of CPAP therapy and after 6 months of CPAP therapy in patients with obstructive sleep apnea.
A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/day) in Children and Adolescents with Excessive Sleepiness Associated With Narcolepsy
Mar 2013The primary objective of this study is to characterize the single- and multiple-dose pharmacokinetics of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) in children and adolescents with excessive sleepiness associated with narcolepsy.
Obstructive Sleep Apnoea in Patients With Intermittent Claudication (WITH-SAS)
Feb 2013The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.
Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study
Feb 2013To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform
Targeted Hypoglossal Neurostimulation Study #2 (THN2)
Feb 2013The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
Feb 2013This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS) during 8 weeks
Aspirin Resistance and Sleep Apnea (AREAS)
Feb 2013The main objective of our study is to analyze the influence of sleep apnea on the response to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.
Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
Jan 2013The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.
Sleep Apnoea Syndrome Without Chronic Heart Failure
Jan 2013It is the objective of this study to collect scientific data of sleep apnoea syndrome patients´ cardiac and respiratory function by additional sensors.
Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients
Jan 2013This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with moderate to severe obstructive sleep apnea. Patients will be randomized to receive zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5 month open extension part will follow when patients in the tablet groups will all receive zonisamide. Patients in the open CPAP group will continue with CPAP treatment. Study hypothesis: Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is hypothesized that zonisamide has a direct pharmacological effect on respiratory control during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction of sleep disordered breathing.
Auricular Acupuncture and Cognitive Behavioral Therapy Treatment for Insomnia (NADA)
Jan 2013The aim of the study is to investigate if AA is as effective as CBT to treat insomnia for patients who have stopped using benzodiazepine-like sleep medicine.
Double blind randomized study to assess the efficacy of BF2.649 compared to placebo in add-on to sodium oxybate in the treatment of narcoleptic patients with residual excessive daytime sleepiness (EDS) during 8 weeks.
Nov 2012To show relevant beneficial effect of BF2.649 on EDS compared to placebo in add on to sodium oxybate in narcoleptic patients with residual EDS. This trial will characterize the efficacy of BF2.649 compared to placebo in showing an incremental improvement to the situation achieved by the use of sodium oxybate particularly in terms of a reduction of EDS as measured by the Epworth Sleepiness scale (ESS). In addition the change in the average number of cataplexy attacks per week will be assessed.
Obstructive Sleep Apnea Syndrome (OSA) and Getemed (GETEMED)
Oct 2012It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital. Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.
Phase shift in adult ADHD of sleep and apetite.
Sep 2012To investigate the best treatment of the Delayed Sleep Phase Syndrome in adults with ADHD.
An open label study with objective sleepregistration on the effects of Doxazosin as treatment for PTSD, especially for sleep disturbance
Aug 2012The purpose of this study is to evaluate the effect on sleep and ptsd of the drug doxazosin in patients with PTSD who also have sleep problems.
An extension open-label safety study of a 24-month 20mg dose regimen of tasimelteon for the treatment of non-24-hour sleep-wake disorder (n24hswd) in blind individuals with no light perception who have enrolled in other tasimelteon clinical trials
Aug 2012The primary objective of this study is to characterize the effect of tasimelteon, 20 mg/night for 24 months, on standard measures of subject safety.
A randomized, double blind study comparing BF2.649 (Pitolisant) to placebo in two parallel groups on the weekly frequency of cataplexy attacks and Excessive Daytime Sleepiness in narcoleptic patients with cataplexy
Aug 2012The main objective is the measure of the anticataplectic efficacy of BF2.649 compared to placebo, assessed by the change in the average number of cataplexy attacks per week between the 2 weeks of baseline and the 4 weeks of stable treatment period.
Effect of reduced cholinergic transmission by rocuronium on the hypoxic ventilatory response in patients with obstructive sleep apnea - before and after three months of continous positive airway pressure treatment. A non-radomised, non-blinded study
Jan 2012How does residual neuromuscular blockage effect the acute hypoxic ventilatory response in patients with obstruktive sleep apnea syndrom before and after 3 months of continouse positive airway pressure treatment?
Efficacy of agomelatine on sleep disturbance in Autism Spectrum Disorder (ASD)
Nov 2011To study the efficacy of agomelatine in improving the quantity and quality of sleep in patients with ASD as recorded by an integrated variable TAP.
Internet-CBT for Insomnia (IpsyInsomni)
Oct 2010This study includes two sub-trials.Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.
A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial
Aug 2010This study will test the impact of a cognitive-behavioural self-management approach for the management of insomnia among patients with chronic pain.
A double-blind, parallel group, randomized, placebo controlled study of the efficacy of Circadin® 2mg in alleviating sleep disturbances in patients with mild to moderate Alzheimer Disease (AD) treated with Acetylcholinesterase (AChE) inhibitor.
Aug 2010To compare the effect of Circadin® to that of placebo, on sleep quality as assessed by the Daily Sleep Diary after 12 weeks of the double-blind treatment period.
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
May 2010To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.
Assessment of Sleep Complaints in Brain Tumor Survivors
Apr 2010Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness.However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors.Children ages 8 to 18 years of age who are active patients in the After Completion of Therapy Clinic and are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.
Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD (ISS)
Mar 2010The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only nighttime symptoms but also significantly reduces conscious awakenings associated with gastroesophageal reflux and consequently improves sleep quality.
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients with Primary Insomnia
Jan 2010To evaluate the safety and tolerability of of MK-4305 for up to 12 months of treatment
Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
Dec 2009This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform.
Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
Nov 2009Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.
Association Between Low Back Pain and Quality of Sleep
May 2009A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic low back pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.
Acupuncture for the Treatment of Insomnia
Mar 2009Insomnia is a common and disabling condition associated with psychiatric and medical comorbidities and often persists despite currently available treatments. Acupuncture has been reported to benefit individuals with insomnia and can decrease hyperarousal. This blinded RCT will investigate the impact of a standardized acupuncture protocol on insomnia, daytime symptoms, and hyperarousal.
Sleep and Obesity in Teenagers
Feb 2009This study aims to investigate 1.whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers, 2.the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers
Efficacy and safety of eplivanserin 5mg/day in insomnia characterized by sleep maintenance difficulties: a 6-week, randomized, double-blind, placebo-controlled, polysomnography study
Nov 2008To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients
Mindfulness-Based Approaches to Insomnia
Oct 2008The overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among individuals with psychophysiological insomnia. Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control condition at reducing arousal levels. Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the MBSR and control conditions at improving sleep parameters. Specific Aim 3: To investigate the relationship between measures of arousal (self-report and objective measures) and sleep (self-report and objective measures) to enhance the understanding of the role of arousal in psychophysiological insomnia.
Multi center, double blind, randomized, placebo controlled, active reference, parallel group polysomnography study to assess the efficacy and safety of a 16 day oral administration of ACT 078573 in adult subjects with chronic primary insomnia.
Aug 2008To demonstrate an effect of ACT-078573 at 200 mg at treatment start and at 16 days on a set of objective sleep-maintenance endpoints and over 2 weeks on a subjective sleep-maintenance endpoint.
Residual effects of zopiclone 7.5 mg on cognition and driving performance in insomnia patients chronically using hypnotics
Jun 2008To determine whether the residual effects of zopiclone 7.5 mg on driving performance in patients complaining of insomnia and who chronically use hypnotics differ from the effects in insomnia patients who do not regularly use hypnotics and from matched healthy controls.
Behavioral Insomnia Therapy For Those With Insomnia and Depression
Feb 2008This study is a randomized clinical trial to test the efficacy of Cognitive-Behavioral Insomnia Therapy when used in isolation or in combination with antidepressant medication (escitalopram) among patients with Major depressive disorder and insomnia.
A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.
Dec 2007To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the average of subjective Total Sleep Time (TST) during month 4 to month 6, as recorded daily in the sleep diary.
Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Nov 2007Determine the influence of methylphenidate treatment on sleep-wake rhythm and endogenous melatonin rhythm in children with ADHD.
Prazosin as add-on therapy in the pharmacological treatment of sleep disturbances in post traumatic stress disorder, a placebo-controlled study using polysomnography
Aug 2007Efficacy of prazosin in PTSD related sleep disturbances, as measured with polysomnography and self administered sleep questoinnaires
Effects of insomnia and chronic use of hypnotics on driving performance
Jun 2007The primary objective of the study is to compare over-the-road driving performance of treated and untreated patients complaining of insomnia, with that of healthy controls matched for age, gender and annual mileage.
Monitoring des états cognitifs chez des sujets volontaires sains, sur 2 périodes, l'une avant et après administration d'une dose unique de Zolpidem, l'autre sans administration de traitement
Apr 2007It's a phase II study performed on healthy volonteers. Zolpidem (DCI) will be administered to the volunteers in order to inducing a drowsiness and a hypoattentiveness. Zolpidem is indicated in the treatment of occasional and transitory insomnia.
Efficacy and safety of 2 mg/day M100907 on Sleep Maintenance Insomnia: a 6-week, multicenter, randomized, double-blind, placebo-controlled Polysomnographic study
Apr 2007Efficacy of M100907 - 2 mg/day in comparison to placebo for Sleep Maintenance Insomnia using change from baseline at 6 weeks of treatment of night polysomnography (NPSG) wake time after sleep onset (WASO).
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