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Sleepiness clinical trials

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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: NCT05706649 Completed - Drowsiness Clinical Trials

A Study of Plant-based Diet on Postprandial Sleepiness

Start date: January 31, 2023
Phase: N/A
Study type: Interventional

This research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness.

NCT ID: NCT05585515 Completed - Sleep Deprivation Clinical Trials

Metabolomics-based Sleepiness Markers

ME-SMART
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Estimating that people sleep on average up to two hours less over the last decades, sleepiness and fatigue need to be considered as significant societal problems of the modern world. Jurisdiction is precise on how to deal with overtired offenders since they were not allowed to use machines or vehicles in the first place, similar to drunk individuals or consumers of illicit drugs. In contrast to alcohol or illicit drug use, however, there are no quick roadside or workplace tests as objective (analytical) biomarkers for sleepiness. Investigators hypothesize that increasing sleep drive or impaired wakefulness can be assessed by qualitative or quantitative fluctuations of certain metabolites in biological specimens, e.g., accumulation or decrease of endogenous substances related to sleep debt. Thus, this sleep study provides the necessary biological samples of either sleep-deprived, sleep-restricted, or control subjects, which are then analysed for appropriate metabolite biomarkers utilizing an untargeted metabolomics approach. In addition to established impairment tests, a state of the art driving simulator will be employed to objectively measure driving performance under all study conditions. Participants will also rate their subjective sleepiness using validated questionnaires.

NCT ID: NCT05464342 Completed - Fatigue Clinical Trials

Integral Physiological Adaptations to Carbohydrate Periodization

IPACP
Start date: July 5, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effect of long-term carbohydrate periodization protocols on sleep architecture, sleep quality, daytime sleepiness, physical performance, body composition, gut microbiome, and miRNA in healthy trained individuals.

NCT ID: NCT05383690 Completed - Sleepiness, Daytime Clinical Trials

Effects of Litebook EDGE™ Phototherapy on Academic Performance and Brain Activity

LiteBook
Start date: March 27, 2017
Phase: N/A
Study type: Interventional

As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late. High school typically starts early in the morning and a significant percentage of normal adolescents arrive at school each day with an insufficient amount of sleep, which can take a substantial toll on their academic performance. As the primary reason for insufficient sleep is a naturally occurring propensity to stay up later in the evening it seems plausible that bright light treatment (BLT) at the appropriate time may phase advance biological clocks and potentially reverse this problem. Hence, the investigators are testing the hypothesis that consistent morning use of a light emitting diode (LED) BLT device (LiteBook Edge™) by healthy adolescents will shift the phase of their sleep wake cycle and enable them to receive an increased amount of sleep during the school week and perform better on tests of attention and academic performance and evidence signs of improved alertness. Alternatively, BLT could potentially enhance alertness through other mechanisms, such as a direct arousing effect, without exerting a discernible effect on circadian phase or sleep duration.

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: 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: NCT05055271 Completed - Clinical trials for Obstructive Sleep Apnea

Delphi Consensus Excessive Daytime Sleepiness in OSA

Start date: April 1, 2021
Phase:
Study type: Observational

The objective of this study is to generate expert consensus statements on the differential diagnosis, definition, and management of EDS in patients with OSA who are adequately treated with primary therapy.

NCT ID: NCT05047367 Completed - Anxiety Clinical Trials

The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome

Start date: January 13, 2021
Phase:
Study type: Observational [Patient Registry]

The most common entrapment neuropathy symptoms, the diagnosis of CTS, is determined by examination findings and by means of the results of electro-diagnostic test. With an increase in disease severity, trap neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness.

NCT ID: NCT05008341 Completed - Clinical trials for Obstructive Sleep Apnea

Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration

Start date: August 27, 2021
Phase: Phase 1
Study type: Interventional

The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug. The study also aims to estimate the potential daily solriamfetol dose received by the infant from the breast milk of the nursing mother. The safety and tolerability of single oral doses of solriamfetol will also be assessed.