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Sleepiness clinical trials

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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.

NCT ID: NCT04942574 Recruiting - Sleep Deprivation Clinical Trials

Voice Biomarkers to Predict Excessive Daytime Sleepiness

SOMVOICE
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

This study aims at measuring the impact of a night of sleep deprivation over the vocal characteristics of healthy subjects.To do so, the subjects takes a Multiple Sleep Latency Test (MSLT) the day after a night of total sleep deprivation (or a supervised normal night for the control subjects). Before each iteration of the MSLT, the subjects are recorded during the reading of a text and fill three medical questionnaires : Karolinska Sleepiness Scale (KSS), Visual Analogue Scale for Fatigue (VAS-F) and Visual Analogue Scale for Anxiety (VAS-A), allowing to link variations of vocal markers to the variations of these measures.

NCT ID: NCT04926350 Completed - Pain Clinical Trials

Resistance Exercise Breaks Improve Ratings of Discomfort and Fatigue in College Students (REX)

REX
Start date: April 9, 2018
Phase: N/A
Study type: Interventional

The purpose of this investigation is to determine the impact of simple resistance exercise breaks on physical activity and prolonged sedentary behavior as well as on ratings of discomfort, fatigue, and sleepiness. Participants will be enrolled in a cross-over designed study, where they will be assessed for normal activity patterns and ratings of discomfort, fatigue, and sleepiness during a typical week and compared to a week where they engage in hourly resistance exercise breaks. Subjects will also complete a feasibility questionnaire at the end to determine if such programming could be implemented into daily living. The hypothesis is that engaging in these simple, hourly resistance breaks will result in decreased ratings of discomfort, fatigue, and sleepiness as well as ratings of high feasibility for implementation of similar resistance exercise programming into their normal, everyday life. Total time spent enrolled in the study will be 4 weeks, however, the participants will only need to report to the lab on 5 different occasions totaling 120 minutes split over those 5 days. Visit one will be roughly 60 minutes long, with the following 4 visits taking roughly 15 minutes each with a visit at the beginning of the week and end of the week for both the control and experimental week.

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: NCT04870372 Completed - Parkinson Disease Clinical Trials

Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease

Start date: March 1, 2020
Phase: Phase 4
Study type: Interventional

This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.

NCT ID: NCT04800939 Completed - Sleep Clinical Trials

The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness

Start date: March 28, 2021
Phase: N/A
Study type: Interventional

This randomized controlled trial evaluates the effect of acupressure application on nurses' sleep quality and daytime sleepiness providing care in surgical clinics. This study hypothesizes that acupressure improves sleep quality and reduces daytime sleepiness.

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: NCT04788953 Recruiting - Clinical trials for Excessive Sleepiness

Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder

Start date: July 21, 2021
Phase: Phase 4
Study type: Interventional

In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).

NCT ID: NCT04761809 Not yet recruiting - Sleep Disorder Clinical Trials

Sleep Duration, Chronic Insomnia, and Subjective Sleepiness in a Sample of Professional Flight Crews

SOMNAVI
Start date: March 2021
Phase:
Study type: Observational

Sleep is a physiological function that plays an essential role in many somatic, cognitive and psychological processes. Although there are many criteria for the effectiveness of sleep, its quantity is unanimously recognized as a major determinant of health. Too little sleep is associated with an increase in metabolic, cardiovascular and accidental morbidity and mortality caused by drowsiness while traveling or at work. Today, the time devoted to sleep is in competition with the time devoted to work, transport or new technologies, in a professional or recreational context. Faced with the public health issues thus raised, research has highlighted the interest of studying the relationships between sleep time and socio-demographic factors, beyond the mere involvement of sleep pathologies. However, among these pathologies, the role of insomnia is not negligible: it is in fact the most frequent sleep disorder (16% of French people in 2010) and represents an important source of involuntary reduction in sleep time, likely to increase inappropriate sleepiness during periods of wakefulness, in the context of activities sometimes involving safety. Flight crews are exposed to specific operational constraints, both in civilian and military environments, which may compromise the sleep recovery function (operational fatigue, extended work amplitudes, repetition of jet lag, etc.). These constraints, which are conducive to compromising the required levels of alertness and cognitive performance, are also at risk of cardiometabolic complications. They therefore raise the issue of risk control and maintenance of air safety. The issue of fatigue in pilots remains an essential issue for the safety of flight operations. Several determinants of operational fatigue in air transport have been identified, such as irregular sleep schedules, large, irregular, and sometimes unpredictable activity amplitudes, sleep debt, night flying, and circadian disruptions related to multiple and repeated time zone changes. While these factors have to deal with rules within airlines that are more often based on "work/rest" than "sleep/wake", current legislation and regulations in the aviation industry are now moving towards scientific approaches to fatigue management in commercial aviation, emphasizing the importance of sleep and taking circadian rhythms into account. In the wake of recent work carried out in the general French population, the conduct of a specific study on sleep time, prevalence and factors associated with chronic insomnia and the complaint of drowsiness among aircrew appears relevant. Due to the specific operational constraints mentioned above, chronic insomnia and sleep debt can be assumed to be more frequent among sailors than in the general population. A better consideration of certain sleep disorders in professional aircrew could allow the adaptation of prevention strategies or countermeasures aimed at optimizing the control of risks with regard to flight safety.