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Sleep Disturbance clinical trials

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NCT ID: NCT05963607 Recruiting - Chronic Pain Clinical Trials

RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain

WB
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.

NCT ID: NCT05956964 Recruiting - Muscle Weakness Clinical Trials

NM Balance Regulation With ULLS and Loss of Sleep

Start date: August 10, 2023
Phase: N/A
Study type: Interventional

The goal of this trial is to learn about how restricted sleep and not bearing weight on the leg affects muscle strength and posture control. Participants will walk exclusively on one leg, sleep at differing intervals, and complete posture tests, muscle strength tests, and muscle imaging. Researchers will compare adequate sleep and restricted sleep to see if muscle strength and posture are affected.

NCT ID: NCT05867290 Recruiting - Stroke Clinical Trials

Music for Sleep After Stroke

MUSAS
Start date: February 22, 2023
Phase: N/A
Study type: Interventional

Sleep difficulties are common following stroke yet effective evidence-based interventions for improving sleep in this population are lacking. A small number of studies have investigated the use of music listening as a way to improve sleep in adults with insomnia. This study aims to examine whether a mindful music-listening intervention can reduce subjective and objective insomnia symptoms and improve mood and fatigue post-stroke. Six adults with a clinical diagnosis of stroke presenting with an insomnia disorder will be recruited from stroke services within NHS Greater Glasgow and Clyde. A multiple baseline single case experimental design will be employed. Participants will be randomly allocated to a baseline phase of 7, 11 or 15 days, followed by a five-week mindful music-listening intervention incorporating sleep hygiene. Changes in subjective and objective sleep will be measured using questionnaires and actigraphy, respectively. Mood and fatigue will also be measured. The data will be analysed using visual inspection, Tau-U and multi-level modelling.

NCT ID: NCT05838014 Recruiting - Aging Clinical Trials

Acute Sleep Deprivation on Whole-body Heat Exchange During Exercise-heat Stress in Young and Older Men

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Sleep deprivation has long been thought to modulate thermoregulatory function. Seminal work on sleep deprivation and thermoregulation has demonstrated that sleep-deprived individuals experience greater elevations in core temperature during exercise-heat stress due to reductions in the activation of local heat loss responses of cutaneous vasodilation and sweating. However, it remains unclear 1) if reductions in local heat loss responses would compromise whole-body heat loss (evaporative + dry heat exchange) and 2) if differences exist, are they dependent on the heat load generated by exercise (increases in metabolic rate augments the rate that heat must be dissipated by the body). Further, much of the understanding of the effects of sleep deprivation on thermoregulation has been limited to assessments in young adults. Studies show that aging is associated with reduction in cutaneous vasodilation and sweating that compromise whole-body heat loss exacerbating body heat storage during moderate- and especially more vigorous-intensity exercise in the heat. However, it remains unclear if sleep deprivation may worsen this response in older adults. The purpose of this study is therefore to evaluate the effects of sleep-deprivation on whole-body total heat loss during light, moderate, and vigorous exercise-heat stress and to assess if aging may mediate this response. To achieve this objective, direct calorimetry will be employed to measure whole-body total heat loss in young (18-30 years) and older (50-65 years) men during exercise at increasing, fixed rates of metabolic heat production of 150 (light), 200 (moderate), and 250 W/m2 (vigorous) in dry heat (40°C, ~15% relative humidity) with and without 24 hours of sleep deprivation.

NCT ID: NCT05837819 Recruiting - Alzheimer's Disease Clinical Trials

Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Start date: February 14, 2023
Phase: N/A
Study type: Interventional

Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.

NCT ID: NCT05820919 Recruiting - Alzheimer Disease Clinical Trials

Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase

40Winks
Start date: September 7, 2023
Phase: N/A
Study type: Interventional

This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.

NCT ID: NCT05803499 Recruiting - Quality of Life Clinical Trials

Rest to Overcome Loss and Reduce Risk

RESTore Plus
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and optimize a targeted behavioral intervention for sleep disturbance among individuals who have recently lost a spouse/long-term cohabitating partner. In the first phase of this study, patient focus groups were conducted to gather information about the unique sleep challenges experienced by spousally bereaved individuals and the kinds of support they would like to receive from a program based on Cognitive Behavior Therapy for Insomnia (CBT-I). In the second phase of the study, a two-arm randomized controlled trial will be conducted to compare changes in sleep and inflammation among participants in the targeted CBT-I intervention to those in an information-only control. Participants will be asked to attend two in-person visits (at baseline and, approx. 8 weeks later, at post-treatment) to provide a blood sample and have vital signs and basic anthropometric measurements (height, weight, waist circumference) taken. After their baseline visit, participants will be randomized into either the targeted CBT-I intervention or the information-only control. The targeted CBT-I intervention will entail 6 online sessions (approx. 50 mins. each) delivered via videoconference by a trained facilitator, once per week over the course of approx. 6 weeks. The information-only control will entail 1 online session (approx. 50 mins.) delivered via videoconference by a trained facilitator. Sleep data (collected via both actigraphy watches and patient self-report sleep diaries) and data on mood, grief, and sleep habits will be collected from participants at three timepoints (baseline, post-treatment, and then again at a 6-month follow-up).

NCT ID: NCT05778812 Recruiting - Insomnia Clinical Trials

Online Insomnia Treatment Program

Start date: August 11, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate improvements in sleep by comparing two 6-week digital programs, either online or app-based, that deliver Cognitive Behavioral Therapy for Insomnia (CBT-I), the "gold standard" treatment for insomnia, with or without a bedside device to help track sleep.

NCT ID: NCT05771558 Recruiting - Parkinson Disease Clinical Trials

The Effect of a Lighting Intervention on Sleep in Parkinson Disease

Start date: November 14, 2022
Phase: N/A
Study type: Interventional

50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.

NCT ID: NCT05757414 Recruiting - Parkinson Disease Clinical Trials

Lighting Intervention to Improve Sleep

Start date: November 16, 2021
Phase: N/A
Study type: Interventional

50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance, will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.