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Sleep clinical trials

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NCT ID: NCT04984824 Completed - Sleep Clinical Trials

Effects of Varying Duration of Naps on Cognitive Performance and Memory Encoding

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

To evaluate the nap duration that achieves maximal cognitive gain with practicality of implementation, the present work employs a within-subject design comparing nap durations of 10 minutes, 30 minutes, and 60 minutes with a no nap condition on benefits to alertness, vigilance, mood, speed of processing and memory over post-nap intervals of 5 minutes, 30 minutes, 60 minutes and 240 minutes. The effect of nap duration on memory encoding will also be examined.

NCT ID: NCT04983680 Completed - Clinical trials for Coronary Artery Disease

Remote-delivered MBCT for SCAD Survivors

Start date: November 4, 2021
Phase: Phase 1
Study type: Interventional

Spontaneous coronary artery dissection (SCAD) is an important cause of cardiac events, primarily affecting young healthy women with no cardiovascular risk factors. The 10-year recurrence rate is 30%, but SCAD recurrence cannot be predicted. Approximately half of SCAD survivors struggle with significant anxiety and fear of recurrence (FOR), which contributes to poor sleep and physical inactivity and, thereby, increased risk of recurrence. Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention with evidence to improve FOR and health behaviors (sleep, physical activity), through psychological mechanisms that directly target key FOR processes (interoceptive bias, intolerance of uncertainty). I adapted MBCT to target FOR, sleep, and physical activity in cardiac event survivors via group videoconferencing delivery (UpBeat-MBCT), however this intervention has not yet been targeted to SCAD survivors. I propose an open pilot trial to test the feasibility, acceptability, and changes in psychological and behavioral health variables in SCAD survivors participating in UpBeat-MBCT (N=16). Participants will be recruited from the MGH SCAD Program and asked to complete self-report surveys and actigraphy before and after the intervention. The primary outcomes are feasibility and acceptability of the intervention and research procedures. Exploratory outcomes are changes in psychological and behavioral variables and their inter-correlations. This project would be the first and only behavioral intervention for SCAD survivors and would provide preliminary data for an NIH Stage II efficacy trial to develop an accessible and efficacious intervention for a vulnerable group of SCAD survivors, with generalizability to survivors of other cardiac events.

NCT ID: NCT04978441 Completed - Clinical trials for Diabetes Mellitus, Type 1

The Influence of Personality Characteristics and Emotions on Blood Glucose Levels Among Type 1 Diabetes Mellitus Patients

Start date: February 17, 2020
Phase:
Study type: Observational

The research goal is to find a correlation between patient personality characteristics, patients' mood and glycemic control. Eventually, using this information may allow treating physicians the ability to better balance glucose blood levels in patients with T1DM, by recognizing influencing psychological parameters. The conclusion from this research will add to other physiological parameters that are being studied today, and in the future will be integrated into an artificial pancreas. The investigators believe that there is a correlation that hasn't been studied in the past between personality characteristics, daily emotions and the ability to balance glucose blood levels in patients with T1DM.

NCT ID: NCT04963205 Recruiting - COPD Clinical Trials

Sleeping Position Study in COPD Patients

Start date: January 17, 2022
Phase: N/A
Study type: Interventional

Background: Chronic obstructive pulmonary disease (COPD) is a common chronic disease characterized by persistent respiratory symptoms and airflow restriction, due to airway and/ or alveolar abnormalities usually caused by significant exposure to harmful particles or gases, in particular cigarette smoking. Sleep disorders are common in society and it is not surprising that they also affect individuals with COPD. Patients with COPD, especially those in severe stages of the disease suffer from many sleep disorders and its prevalence varies depending on the disease. Epidemiological studies report that approximately 75% of COPD patients experience nocturnal symptoms of the disease. The most common are sleep-breathing disorders (nocturnal hypoxemia, central sleep apnea, difficulty breathing, sleep-related hypoventilation), insomnia and sensory motor disorders during sleep, including restless legs syndrome. Patients with COPD not only experience poorer sleep quality and concomitant sleep disorders but also have a higher chance of sudden nocturnal death, especially during a period of COPD exacerbation. Scientific studies show that elevated posture during sleep (>30 degrees raised head and back from the supine position) has a positive effect on sleep quality. To date, this has not been proven in patients with COPD who are a special group with sleep disorders. Research questions and objectives: The primary study objective is to evaluate if adjusted sleeping position with electrical bed backrest improves the quality of sleep in patients with COPD. The exploratory objectives are: 1. To evaluate if adjusted sleeping position improves total sleep time, respiratory patterns, oxygen saturation and heart rate (measured by CASIS, WatchPat and Sleepiz). 2. To investigate if adjusted sleeping position decreases COPD-related symptoms during sleep and daytime (measured with CAT score). 3. To evaluate if adjusted sleeping position reduces patient's fatigue during the day (measured with FSS questionnaire). 4. To evaluate if better sleep at night is associated with more energy, more activity and less breaks for rest during the day (measured with OQ-S, 6MWT and smartwatch). 5. To compare the results from the two sleep recording technologies (single night minimal contact sleep recorder-WatchPat versus several nights without contact sleep recorder-Sleepiz). Study design: Prospective, open label, cross-over clinical trial with randomized treatment order. Every subject will use the assigned intervention for 4 weeks. The intervention is an electrical bed backrest used during sleep time. The randomization will be non-adjusted, in ratio 1:1. A total of 40 patients will be included in the study.

NCT ID: NCT04953754 Active, not recruiting - Sleep Clinical Trials

Melatonin and Vaccine Response, Immunity, and Chronobiology Study

MAVRICS
Start date: October 25, 2022
Phase: N/A
Study type: Interventional

This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.

NCT ID: NCT04946994 Recruiting - Hiv Clinical Trials

Relationship of Exercise, Sleep, and Inflammation Markers in People Living With HIV

REST
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this randomized clinical trial is to characterize the effects of two exercise interventions, high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME), on sleep and inflammation in older people living with HIV (PWH). This study is a sub-study associated with The High Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults with HIV (HEALTH-HIV; NCT04550676). The investigators propose the following aims: Aim 1. Compare the effectiveness of HIIT and CME exercise interventions on sleep in older PWH. Aim 2. Quantify inflammation markers associated with sleep quality (self-report surveys) in older PWH at baseline, between (week 8) and after exercise interventions (HIIT and CME) (week 16). The investigators hypothesize HIIT will lead to greater improvement in sleep quality (duration and quality) compared to CME and older PWH who experience poor sleep quality and the CME intervention will have increased inflammation markers compared to older PWH who experience better sleep quality and the HIIT intervention. The intervention is being delivered by research personnel at the University of Washington associated with the HEALTH-HIV study (NCT04550676). Data for this study will only be collected at the University of Washington site of the HEALTH-HIV study.

NCT ID: NCT04943562 Recruiting - Insomnia Clinical Trials

Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging

Start date: August 1, 2021
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation. Three domains of devices will be used: Movement sensors, wearable EEG band and smartphones The project will be composed of two stages: In the first stage, the use of the combination of actigraphy and EEG will be used for sleep staging in a sample of 12 healthy volunteers from 20 to 40 years old, both genders and with no sleep disorders for each combination of ACT+EEG. Considering there will two of each (thus four combinations), the final sample will be composed of 48 individuals. Once recruited, evaluated according to the inclusion and exclusion criteria and consented with the terms of this study, the participants will be referred to the sleep lab, in which they will undergo a full night type-1 in lab polysomnography, following the setup recommended by the American Academy of Sleep Medicine. Concomitantly with the polysomnography, the participants will also use the combination of ACT+EEG. In the second stage, the most successful combination tested in the first stage will be tested in a clinical sample, composed by 60 participants from both genders, from 20 to 60 years old and with at least one sleep disorder or complaint. Among these, at least 30% of the sample should have moderate to severe insomnia, 30% should have high risk to sleep apnea and 70% should have excessive sleepiness scale. All the procedures, including the polysomnography will be performed identically to the first step.

NCT ID: NCT04934449 Completed - Sleep Clinical Trials

Occlusal Splints in the Treatment of Sleep Bruxism

bruxism
Start date: August 6, 2021
Phase: N/A
Study type: Interventional

Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material. In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep quality and occlusal force parameters of patients with sleep bruxism.

NCT ID: NCT04932096 Recruiting - Critical Illness Clinical Trials

Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin

SMARTKids
Start date: January 2, 2023
Phase: Phase 2
Study type: Interventional

Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge. Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.

NCT ID: NCT04932044 Recruiting - Quality of Life Clinical Trials

Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research. The proposed study has six specific aims: 1. Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home. 2. Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home. 3. Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home. 4. Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home. 5. Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home. 6. Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.