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Sleepiness clinical trials

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NCT ID: NCT04176042 Completed - Daytime Sleepiness Clinical Trials

Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea

Start date: November 18, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to examine daytime sleepiness in a community context. This includes examining sleepiness in a large sample in terms of social/behavioral/environmental predictors and health-related outcomes, as well as examining the role of a sleep education intervention in a smaller sample for promoting healthy beliefs/attitudes about sleepiness.

NCT ID: NCT04156789 Completed - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnoea in Sarcoidosis

OSASA
Start date: October 28, 2019
Phase:
Study type: Observational

Sarcoidosis is a multisystemic granulomatous disease of unknown origin. Fatigue is a common problem in sarcoidosis affecting between 50% and 80% of patients, and thus represents a major impairment of their quality of life. The findings of recent studies suggest a high prevalence of obstructive sleep apnoea (OSA) in patients with sarcoidosis, estimating a range from 17% to 67%. Pathomechanisms leading to this increased OSA prevalence are still unclear, yet likely to be multifactorial including sarcoid myopathy and neuropathy leading to impaired integrity of the upper airways as well as corticosteroid induced obesity. While both diseases, Sarcoidosis and OSA, could lead to fatigue and excessive daytime sleepiness (EDS) the current managing strategies differ significantly. OSA patients are mostly treated with continuous positive airway pressure (CPAP) whereas sarcoidosis associated fatigue may require increased immunosuppressive therapy. Little is known about treatment of fatigue and sleepiness in patients suffering from both conditions.This study aims to close this knowledge gap and define prevalence of OSA in a swiss cohort with sarcoidosis patients. Therefore, we plan a prospective, observational, controlled study to investigate the prevalence of sleepiness, fatigue, life quality and obstructive sleep apnoea in patients with Sarcoidosis. Patients treated in the University Hospital Zurich due to sarcoidosis will be invited by letter to take part in this study. After confirmed consent and baseline assessments at the University Hospital Zurich, these patients will undergo a single night, in-home sleep study to assess possible OSA. Sleepiness and fatigue specific questionnaires and in-home respiratory polygraphy (oRP) are obtained in all subjects. To assess inflammation status and other conditions connected to sleepiness like hypothyroidism and anaemia, sarcoidosis patients will undergo blood sampling.

NCT ID: NCT04091425 Completed - Clinical trials for Obstructive Sleep Apnea

Study of TAK-925 in Participants With Obstructive Sleep Apnea (OSA) Who Are Experiencing Excessive Daytime Sleepiness (EDS) Despite Adequate Use of Continuous Positive Airway Pressure (CPAP)

Start date: November 21, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA) who are experiencing excessive daytime sleepiness (EDS) despite adequate use of CPAP as the primary OSA therapy.

NCT ID: NCT04020991 Completed - Clinical trials for Obstructive Sleep Apnea

Sleepiness and Tiredness Among Doctors Working in A Tertiary Hospital

Start date: October 1, 2018
Phase:
Study type: Observational

Sleep disorders are important health issues that can reduced ones quality of life by affecting their performance and productivity in a negative way. People who work in shifts or doing 24 hours call usually have irregular sleep patterns and often complaint of fatigue and daytime sleepiness. This will jeopardized our attention, concentration ability and memory which may lead to serious job accidents. This study is to screen for obstructive sleep apnea among doctors working in a tertiary hospital and to determine the predictors of OSAS and tiredness among doctors who frequently work night shifts or 24 hour call. What would this involve? Participant will be required fill up demographic data and answer the STOP-Bang and Epworth sleepiness scale questionnaires. After that participant will need to wear a wrist watch pulse oximeter just before going to sleep at night until the next morning (minimum of 6 hours of sleep required). The wrist watch will then be returned to researcher the following day for data analysis purpose. The benefits We hope to screen and identify those who are at risk of having obstructive sleep apnea and start early treatment among doctor who often have irregular sleep patterns and insufficient sleep due to the nature and timing of their work.

NCT ID: NCT03881852 Completed - Narcolepsy Clinical Trials

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

CONCERT
Start date: January 30, 2019
Phase: Phase 2
Study type: Interventional

CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.

NCT ID: NCT03629834 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.

SAHOS-TIME
Start date: January 25, 2018
Phase:
Study type: Observational

Presently, there isn't any international recommendation to evaluate vigilance in Obstructive Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend evaluating professional driver with a MWT but no recommendation exists for other patients. After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the MWT or a subjective one. In the university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale, tiredness score of Pichot, and depressive score of Beck are performed.

NCT ID: NCT03624920 Completed - Parkinson Disease Clinical Trials

Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness

Start date: July 12, 2018
Phase: Phase 2
Study type: Interventional

This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.

NCT ID: NCT03194217 Completed - Parkinson Disease Clinical Trials

BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

CASPAR
Start date: November 10, 2017
Phase: Phase 2
Study type: Interventional

This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with Parkinson's disease.

NCT ID: NCT03130803 Completed - Sleep Deprivation Clinical Trials

Biomarkers of Insufficient Sleep and Sleepiness

Start date: January 19, 2017
Phase: N/A
Study type: Interventional

Sleep and wakefulness disorders impact 50 to 70 million Americans and insufficient sleep is epidemic with over 50% of Americans reporting less than 7 hours of sleep per night. Health problems associated with insufficient sleep include inflammation, depression and anxiety, diabetes, stress, drug abuse, poor quality of life, obesity, and fatigue related accidents on the job/while driving. While the contribution of sleep to overall health, well-being, and public safety is recognized, no established clinical biomarkers of sleep deficiency exist. Such biomarkers would have utility as road-side biomarkers of sleepiness (e.g., drowsy driving), monitoring on the job fatigue/fitness for duty (e.g., transportation, military ops health care), monitoring sleep health, as well as for clinical diagnostics and measures of clinical treatment outcomes. Thus, investigators designed a controlled laboratory insufficient sleep protocol utilizing metabolomics to identify biomarkers of insufficient sleep. Investigators propose to identify changes in metabolites that consistently occur during insufficient sleep. As an exploratory outcome investigators will examine associated changes in metabolites and cognitive performance during insufficient sleep.

NCT ID: NCT03037203 Completed - Parkinson Disease Clinical Trials

A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness

Start date: January 2017
Phase: Phase 2
Study type: Interventional

This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.