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Sleep Wake Disorders clinical trials

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NCT ID: NCT05736692 Withdrawn - Sleep Disorder Clinical Trials

Addressing Sleep in Adolescents Post-Concussion ("ASAP Study")

ASAP
Start date: January 30, 2024
Phase: N/A
Study type: Interventional

Hundreds of thousands of adolescents experience protracted recoveries from concussion, which can affect all aspects of their lives and create family and societal burden. Research suggests that interventions to improve their sleep quantity and/or quality could improve recovery from concussion, but current treatment models are costly and onerous for families, fit poorly with integrated care models, and leave youth and their families to suffer months of protracted burden. This study will evaluate the efficacy of a promising brief behavioral sleep intervention, which could prove to be a powerful new tool to head off protracted symptom burden.

NCT ID: NCT05096130 Withdrawn - Fatigue Clinical Trials

Lifestyle Medicine Strategies for Combating Sleepiness and Fatigue in Professional Drivers

HighWay2Health
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Sleep has a number of health benefits, including memory and learning, vitality and energy as well as high quality of life levels. Lack of sleep impairs judgment, impacts longevity and safety, and increases the risk of a number of diseases including obesity, hypertension, heart disease, diabetes, mood disorders, and impaired immune function. In addition lack of sleep or disturbance of normal sleep cycle could have a major impact on people's lives and working performance such as driving. Daily sleepiness is a problem concerning professions with a non-fixed schedule. Specifically, professional long-haul drivers confront sleepiness problems and in combination with fatigue, they are prone to driving accidents and other incidents. Sleep quality and quantity are closed related to fatigue which is one of the most common reasons for driving and working accidents. In recent years, car accidents involving professional drives have increased significantly. The main reasons for those accidents were fatigue and sleepiness due to long hours of driving or difficult working conditions according to the recent European report (Driver Fatigue in European Road Transport - etf-europe.org). Lifestyle Medicine addresses health risk factors in primary, secondary, and tertiary prevention of developing disease rather than on acute care and reacting to illness, injury, and disease. Lifestyle Medicine strategies targeting modifiable risk factors, such as diet, sleep, stress, and physical activity. By applying those regimes the investigators could improve physical and mental health levels that can affect the quality of sleep, reducing daily sleepiness and fatigue, in professional drivers operating coaches and trucks. Any intervention that could improve alertness and reduce fatigue and sleepiness in those people, will automatically improve safety, reduce driving accidents and save lives and resources.

NCT ID: NCT04875442 Withdrawn - Sleep Disorder Clinical Trials

Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions

MEMOWAVE
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment

NCT ID: NCT04506112 Withdrawn - Sleep Disturbance Clinical Trials

Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

Start date: January 27, 2022
Phase: N/A
Study type: Interventional

The study aims are to: 1) optimize the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for delivery to Veterans in cardiac rehabilitation, 2) test and refine the adapted TranS-C treatment manual and protocol, and 3) conduct a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures.

NCT ID: NCT04266457 Withdrawn - Clinical trials for Sleep Disorder Rem Sleep Behavior

Establishing Alpha-synuclein RT-QuIC Assay as a Diagnostic Technique in REM Sleep Behaviour Disorder

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

We hypothesise that a real-time quaking induced conversion assay for the detection of pathological alpha-synuclein (α -syn RTQuIC) can be used to differentiate between cases of idiopathic REM-sleep behaviour disorder (RBD) and RBD that is symptomatic of prodromal α-synucleinopathies.

NCT ID: NCT03998358 Withdrawn - Clinical trials for Traumatic Brain Injury

Characterization of Fatigue in Military Personnel With Traumatic Brain Injuries

Start date: March 19, 2021
Phase:
Study type: Observational

Background: People who have had a traumatic brain injury (TBI) often experience fatigue. Fatigue is the feeling tired all the time. Researchers want to learn more about how TBI and fatigue are related. Objective: To better understand fatigue after TBI in active duty military and veterans. Eligibility: Active duty service members or veterans ages 25-40 who have sustained at least 1 TBI more than 6 months but less than 5 years ago Design: Participants will be screened with: - Medical history - Physical exam - Blood and urine tests Participants will have Visit 1 the same day as screening. This will include questionnaires and interviews. These will be about their fatigue, quality of life, and health. Participants will wear an activity monitor on their wrist and complete a sleep diary for 7 days at home. Participants will have Visit 2: They will stay in the clinic for 2 nights. The visit will include: - Tests of memory, attention, and thinking - Placement of intravenous (IV) line: A needle will guide a thin plastic tube into the participant s arm vein. - 2 overnight sleeps tests: Participants brain waves will be recorded while they sleep. Small electrodes will be placed on the scalp. Monitors will be placed on the skin. These will measure breathing, heart rate, and movement. Blood will be drawn overnight through the IV line. - Optional hydrocortisone stimulation test: Participants will receive the hormone through the IV line. Blood will be drawn through the IV line 5 times over 1 hour. - Optional MRI: Participants will lie in a machine. This machine is a metal cylinder that takes pictures of the brain.

NCT ID: NCT02931474 Withdrawn - Clinical trials for Traumatic Brain Injury

Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia

Start date: October 6, 2016
Phase: Phase 2
Study type: Interventional

Background: People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone releasing hormone (GHRH) might improve sleep in service members and veterans who have had a TBI. Objective: To see if GHRH can improve sleep in people who have had a TBI. Eligibility: Active duty service members or veterans (active duty in the past 10 years) ages 18-45 who have had a TBI in the past 6 months to 10 years. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Getting ACTH (a hormone) through an intravenous catheter (thin plastic tube) Interview about their mood and alcohol and drug use Questionnaires about their TBI, mood, and sleep Participants will have 2 overnight study visits a couple weeks apart. These will include: Physical exam Urine sample Two intravenous catheters placed. Blood samples will be taken throughout the night. Two shots under the skin of the belly. The shots will be GHRH on one visit and placebo on the other. Spending the night in the sleep lab. Their brain waves will be recorded with electrodes placed on the scalp. A questionnaire in the morning about their sleep Participants will be called a few days after each overnight visit. They will be asked about how they are feeling and to rate their sleep.

NCT ID: NCT02906904 Withdrawn - Sleepwalking Clinical Trials

Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)

NOCISOMNIE
Start date: October 2015
Phase: N/A
Study type: Interventional

Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent and disabling sleep disorders characterized by arousal specifically from slow wave sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state. The investigators recently reported frequent subjective complaints of chronic pain, migraine and headache during wakefulness in adult sleepwalkers. They also described frequent analgesia during severe and injuring episodes, suggesting a relationship between dissociated brain activity and nociceptive dysregulation. However, this study did not included objective nociceptive measures and the retrospective assessment of perceived pain during parasomnia episodes over a lifetime span might also introduce a recall bias. The aims of the present study are to measure objective pain sensitivity in patients with NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS, and 3) wakefulness. Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the nociceptive threshold. During the recovery sleep following the sleep deprivation, the investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive responses. The investigators hypothesized a lower nociceptive threshold during wakefulness in sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This study may help to better understand the etiology and mechanisms underlying the clinical enigma of the nociceptive dysregulation in NREM sleep parasomnias.

NCT ID: NCT02593981 Withdrawn - Sleep Clinical Trials

Addressing Sleep Problems in Older Adults

Start date: March 2018
Phase: N/A
Study type: Interventional

As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals. The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.

NCT ID: NCT02390583 Withdrawn - Internet Addiction Clinical Trials

Internet Addiction and Sleep Disorders

ADDICSOM
Start date: September 2016
Phase: N/A
Study type: Interventional

This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.