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Excessive Daytime Sleepiness clinical trials

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NCT ID: NCT05939453 Recruiting - Body Weight Clinical Trials

Impact of Bright Light Therapy on Prader-Willi Syndrome

PWS-LT
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

NCT ID: NCT05822128 Completed - Clinical trials for Excessive Daytime Sleepiness

Alternative Epworth Sleepiness Scale ESS-ALT in French

SOMNOLD
Start date: June 28, 2023
Phase:
Study type: Observational

The Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire. In elderly subjects, the clinician is often confronted with difficulties in accurately estimating the ESS score and measuring subjective daytime sleepiness. Indeed, according to Onen et al, the ESS tends to underestimate the prevalence of sleep disorders in the geriatric population, mainly due to non-response to problematic items, namely: - Item 3: Sitting, inactive in a public place (cinema, theater, meeting) - Item 8: In a car that has been stopped for a few minutes. In order to overcome this problem, Janine Gronewold's German team has developed and begun work on the validation of an alternative version of the ESS, the ESS-ALT, adapted to the population of interest, in German. The aim of the present work is to adapt the ESS-ALT in French, then to study its correlation with sleep data recorded by nocturnal polysomnography, and among the secondary objectives, to correlate it with sleep latency during iterative sleep latency tests, in order to propose to the clinician a simple, reproducible tool, allowing to measure daytime sleepiness in elderly subjects.

NCT ID: NCT05458128 Active, not recruiting - Clinical trials for Idiopathic Hypersomnia

A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

Start date: August 19, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the long-term safety and effectiveness of pitolisant in patients with idiopathic hypersomnia (IH) who completed the Double-Blind Randomized Withdrawal Phase of study HBS-101-CL-010.

NCT ID: NCT05223166 Completed - Clinical trials for Excessive Daytime Sleepiness

A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA

Start date: April 12, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) not tolerating or refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS.

NCT ID: NCT05113745 Enrolling by invitation - Narcolepsy Clinical Trials

A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy

Start date: October 20, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

NCT ID: NCT05059223 Completed - Narcolepsy Clinical Trials

A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

SYMPHONY
Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

NCT ID: NCT04923594 Completed - Narcolepsy Clinical Trials

Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy

Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.

NCT ID: NCT04886518 Active, not recruiting - Clinical trials for Myotonic Dystrophy 1

Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1

Start date: June 28, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years. The secondary objectives of this study are to assess the impact of pitolisant on fatigue, cognitive function and the burden of disease along with assessing the long-term safety and effectiveness of pitolisant in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.

NCT ID: NCT04789174 Completed - Clinical trials for Obstructive Sleep Apnea

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

SHARP
Start date: May 17, 2021
Phase: Phase 4
Study type: Interventional

The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired cognitive function.

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.