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Sleepiness clinical trials

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NCT ID: NCT02806895 Completed - Clinical trials for Obstructive Sleep Apnea

Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA

Start date: July 5, 2016
Phase: Phase 2
Study type: Interventional

This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to obstructive sleep apnea.

NCT ID: NCT02739568 Completed - Clinical trials for Obstructive Sleep Apnea

Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA

HAROSA3
Start date: April 2016
Phase: Phase 3
Study type: Interventional

The first objective of this study is to demonstrate the efficacy and safety of pitolisant given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS. The secondary objectives of the study include assessing the long-term tolerance as well as the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of Open Label Extension period and further investigating the co-variates or co-medications that affect the pharmacokinetics of pitolisant in the target population.

NCT ID: NCT02720744 Completed - Narcolepsy Clinical Trials

Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

Start date: November 17, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

NCT ID: NCT02348632 Completed - Clinical trials for Obstructive Sleep Apnea

"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

Start date: May 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

NCT ID: NCT02348619 Completed - Clinical trials for Obstructive Sleep Apnea

"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

OSA
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

NCT ID: NCT02348606 Completed - Clinical trials for Obstructive Sleep Apnea

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

OSA
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

NCT ID: NCT02348593 Completed - Narcolepsy Clinical Trials

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"

Start date: May 2015
Phase: Phase 3
Study type: Interventional

This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

NCT ID: NCT02088593 Completed - Depression Clinical Trials

Simulated Dawn Med Students

Start date: July 2007
Phase: N/A
Study type: Interventional

Medical students score higher than the general population on measures of depression, anxiety, fatigue, poor sleep and sleepiness. Data suggest that disparages in circadian phase might contribute to these problems. From an internal validity standpoint, first year medical students are an ideal group to study. The majority of the students will be matched on variables such as education, age, and intelligence. However, more importantly, they have a nearly identical life style when it comes to factors such as schedule, living conditions, level of stress, and timing of stressors. The specific aim and hypothesis is:Medical students randomized to sleep hygiene counseling plus simulated dawn will report less depression, anxiety, fatigue, sleepiness, and sleep disruption (as measured by standardized questionnaires) than students randomized to just sleep hygiene counseling.

NCT ID: NCT02021903 Completed - Clinical trials for Parkinsonian Disorders

Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies

HYPOSOMNPARK
Start date: May 2012
Phase: N/A
Study type: Interventional

Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It is a major complain and represents a socially relevant problem as unintended episodes of sleep can also occur while driving for example. Arterial hypotension is frequently observed in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness is known to occur preferentially when patients are having arterial hypotension whatever the cause (i.e. postprandial period, administration of hypotensive medication such as dopamine agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness. We have observed this association in an on-going epidemiological survey Hyperglycaemia induced by oral glucose load - a standardized model simulating food intake during a meal - provokes arterial hypotension in the majority of Parkinson's disease patients with dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated by this fall in blood pressure.

NCT ID: NCT01681121 Completed - Narcolepsy Clinical Trials

A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy

Start date: September 2012
Phase: Phase 2
Study type: Interventional

This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.