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Sleepiness clinical trials

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NCT ID: NCT06348303 Recruiting - Clinical trials for Healthy Participants

Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg

Start date: March 15, 2024
Phase: Phase 4
Study type: Interventional

Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.

NCT ID: NCT06103825 Recruiting - Clinical trials for Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients With Obstructive Sleep Apnea (OSA)

Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of 12-week solriamfetol administration in the treatment of EDS in patients with OSA from China, using a randomized, double-blind, placebo-controlled, multi-center, parallel-design.

NCT ID: NCT06015646 Recruiting - Self Efficacy Clinical Trials

Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether personalized lifestyle coaching minimizes the negative impact of circadian disruption on performance and recovery in emergency medicine physician trainees during night shifts.

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: NCT05795270 Recruiting - Clinical trials for Sleep Apnea Syndromes

Multicenter Study on the Role of Neurodegeneration Biomarkers in Obstructive Sleep Apnea Syndrome With Residual Excessive Daytime Sleepiness.

EDS in OSA
Start date: December 15, 2020
Phase:
Study type: Observational

Excessive daytime sleepiness which still remains after an effective treatment with nocturnal ventilotherapy or with other specific treatments (positional therapy, oro-mandibular devices) in patients with obstructive sleep apnea syndrome has a prevalence of 55% of treated cases, representing a notable theme of clinical and research interest. In recent years there have been several studies on the use of wakefulness-promoting drugs generally prescribed in patients with narcolepsy, in this disorder with promising results. Right in consideration of the forthcoming approval of these drugs, it is important to find biomarkers able to predict which patients will develop daytime sleepiness resistant to ventilatory treatment. Several studies have highlighted the association between obstructive sleep apnea syndrome and the increase of cerebral amyloid beta deposits, concluding that apnoic disorder can be considered a risk factor for the development of cognitive impairment and Alzheimer';s disease. In this scenario, it would be useful to identify biological markers able to underline which clinical phenotypes of sleep apnea syndrome are more associated with residual excessive daytime sleepiness and/or cognitive impairment. In recent years several kits for the assay of biomarkers of neurodegeneration have been developed not only in CSF, but also in human serum. Among them, the most important are light chain neurofilaments (NFL), amyloid isoforms 40 and 42 (Ab40 and Ab42). Other biomarkers found in neurodegenerative diseases associated with excessive daytime sleepiness are orexin A (OXA) and histamine (HA). In this view, the aim of this study is to evaluate the role of biomarkers of neurodegeneration in characterizing disease severity and response to treatment of obstructive sleep apnea syndrome with residual excessive daytime sleepiness.

NCT ID: NCT05569603 Recruiting - Clinical trials for Circadian Rhythm Sleep Disorder

Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness

Start date: January 12, 2022
Phase: N/A
Study type: Interventional

Poor sleep is closely related to circadian misalignment; shift workers often experience shift work disorder characterized by excessive sleepiness and recurrent shift work schedules-associated insomnia. This study aims to examine the effects of a program of chronobiology-guided lifestyle interventions (CGLI) on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

NCT ID: NCT05183464 Recruiting - Hypersomnia Clinical Trials

Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia

BIOSOM
Start date: April 11, 2022
Phase:
Study type: Observational

Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including narcolepsy and idiopathic hypersomnia). To date, objective measures of sleepiness can only be achieved in laboratory. Subjective techniques as scales and questionnaires are highly sensitive to inter-individual differences and cannot constitute a reliable diagnosis tool of sleepiness. Recent studies suggested that some salivary biomarkers are sensitive to sleep characteristics and thus, may allow the objective and easy evaluation of sleepiness. The objective of the study is to explore the usability of salivary biomarkers (a-amylase and oxalate) as a new non-invasive technique to evaluate sleepiness and to diagnose primary hypersomnia in children. The hypothesis of this study is that there will be a modification of salivary biomarkers concentrations with the variations of diurnal sleepiness.

NCT ID: NCT05041218 Recruiting - Clinical trials for Coronary Artery Disease

Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab

GAME-ON
Start date: May 9, 2023
Phase:
Study type: Observational [Patient Registry]

Improvement of patients' care and outcome is largely based on development and validation of drugs and technologies, especially in rapidly evolving fields as Interventional Cardiology. In fact, even though the optimal efficiency of a cathlab can be influenced by Interventional Cardiologist's mental workload, stress' accumulation and performance, little if any attention is paid to the monitoring and optimization of his/her mental status. Electroencephalogram (EEG)-based neural-interfaces are able to estimate workload, fatigue and the degree of sleepiness through spectral analysis techniques. In particular, the amplitude of alpha waves is a widely validated indicator of mental engagement's level. Developing a low cost and highly feasible device to monitor and analyze operator's mental engagement level and performance could be extremely appealing, especially considering both the lack of data in literature for interventional disciplines and the recent technology developments.

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: 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).