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NCT ID: NCT04502108 Recruiting - Sleep Clinical Trials

Behavior During and After COVID-19 Crisis

Start date: April 1, 2020
Phase:
Study type: Observational

A crisis situation leads to changes in life. During December 2019, many people contracted pneumonia in the Chinese city of Wuhan. On January 7, 2020, the novel coronavirus (Covid-19) was identified as the cause of this disease. Within five months, the virus spread around the globe and forced countries to restrict public life. Due to the high infection rates in Europe, a lockdown followed between March and April 2020 (except in Sweden). As the number of infections decreased, European countries began to gradually relax the lockdown from May 2020. The lockdown and the later stages of loosening have an impact on lifestyle. Institutions of higher education must also adapt to this situation and have switched to distance learning. The University of Applied Sciences of Bern (BFH), Department of Health Professions with the Departments (DHP) of Nutrition and Dietetics and Physiotherapy, considers the question of the degree to which nutritional and exercise behavior has changed. The findings provide recommendations for future crises for students and employees of the BFH-DHP. In order to achieve this, at the BFH-DHP two anonymous online surveys will be conducted.

NCT ID: NCT04499560 Completed - Inflammation Clinical Trials

The Effects of a Nutrition Supplement on Health Related Quality of Life

Start date: August 3, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.

NCT ID: NCT04491110 Completed - Sleep Clinical Trials

Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial

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

Introduction Sleeping problems experienced by cancer patients carers are frequent with 72% of carers reporting moderate to severe problems. Another consequence for this carers is the increase of suffering from depression and it is usually associated to carer overload. Objectives Main objective: - To evaluate the effects of listening to music in sleep quality for oncology patients non-professional carers at home, and to evaluate the influence of specific factors that may modify that effect. Secondary objectives: - To assess the relationship between the waking state and the consequences during the day according to sleep characteristics. These include: 1. Psychological results: 1. Quality of life. 2. Carer overload. 2. Physical results: 1. Sleepiness during the day. 2. Physical activity, intensity and length evaluation. - To assess carers satisfaction with the intervention. Method Randomized clinical trial, single blinding and performed in oncological patients carers in several practices. 2 samples of 40 carers. Intervention group will be taken through a seven session intervention with music; control group will undergo seven sessions of therapeutic education (as a reminder). Results will be evaluated using Pittsburgh Quality of Sleep Index, triaxial accelerometer, EuroQol-5D-5L, Caregiver Strain Index, Epworth Sleepiness Scale and Client Satisfaction Questionnaire. Statistical analysis Basal values will be compared for both groups. Then the values before and after the intervention will be compared using Student's t distribution for normal continuous variables, and Wilcoxon's T test for paired data in continuous not normal variables. A multiple linear regression will be carried out. The system developed for the PREDIMEDPLUS study will be used to process accelerometer data results. This semi-automated system manages data capture in a continuous stream in a central server of Malaga University. Processing and analysis of this data is also centralised, with an open source package, GGIR v. 1.5-1248

NCT ID: NCT04487483 Active, not recruiting - Sleep Clinical Trials

Exploring the Impact of a Sleep App on Sleep Quality

Start date: February 13, 2020
Phase: N/A
Study type: Interventional

Sufficient sleep is crucial for good health, yet a third of UK adults have impaired sleep quality. Therefore, there is urgent need for population-level sleep interventions. However, many sleep interventions (such as Cognitive Behavioural Therapy for Insomnia) are resource intensive and not widely available. Research demonstrates that smartphone interventions are an effective way to reach the wider population. However, many commercially available smartphone sleep applications focus on one technique, and hence do not tailor to the diverse needs of individuals. A new sleep app offers six different techniques, allowing individuals to shape their own journey to improved sleep quality. The investigators aim to test the sleep app's efficacy and gather user experience data to allow app optimisation. The study is a two-arm pilot randomised control trial (RCT). After recruitment and screening, baseline measurements will be taken: subjective sleep quality data will be collected using the Insomnia Severity Index (ISI) and the Consensus Sleep Diary from all participants and objective accelerometry data via an Oura Ring (worn on finger for a week) on a subsample of participants. Participants will then be randomised to the intervention or control. Intervention participants will be given free use of the sleep app for 3 months. Controls will be informed that they will not receive access to the intervention and will be asked to abstain from using any other digital sleep-based intervention during the 3 months. All participants will be given the ISI after each month and will be given the Consensus Sleep Diary to fill out for one week again after 2 months. The planned Oura ring follow-up after 2 months for participants who wore the Oura ring at baseline has been cancelled due to COVID-19. User engagement will be assessed using the Digital Behaviour Change Intervention Engagement Scale. Telephone interviews will also be conducted with 20-30 participants to explore experience of using the app, how the comparison group felt about being allocated to the control group and how the COVID-19 pandemic may have affected their sleep and other measures of the study. Change in self-reported sleep will be the primary outcome and qualitative user data secondary. Appropriate tests (such as an ANOVA or linear regression controlling for baseline sleep and testing for effect of group when using continuous data) and thematic analysis of qualitative interview data will be conducted.

NCT ID: NCT04484649 Completed - Sleep Clinical Trials

Sleeping Healthy/Living Healthy Development

Start date: October 12, 2021
Phase: N/A
Study type: Interventional

This pilot study will: (1) develop Sleeping Healthy/Living Healthy, a school-based health center (SBHC) intervention that combines MBIH and sleep hygiene strategies to improve sleep quality in urban adolescents with poor sleep quality; (2) evaluate the feasibility and acceptability of intervention procedures; and (3) assess the preliminary intervention effects on sleep quality in urban adolescents. This study includes a development phase and a pilot individually-randomized group treatment (IRGT) phase. In Year 1, the investigators will develop the novel integrated intervention using an iterative participatory design process. In Year 2, the investigators will conduct an IRGT trial with 60 adolescents with insufficient sleep recruited from two SBHCs in New York City. Adolescents will be randomized 1:1 to receive the intervention or an attention control of equal intensity and duration. Process evaluation interviews guided by a rigorous fidelity framework with adolescents and with SBHC providers and personnel will be conducted to obtain feedback regarding intervention procedures.

NCT ID: NCT04478305 Not yet recruiting - Sleep Clinical Trials

Affect of Duavive on Mood & Anxiety Symptoms

DOMA
Start date: March 2021
Phase: Phase 1
Study type: Interventional

This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.

NCT ID: NCT04477577 Completed - Physical Activity Clinical Trials

First Heroes: Engaging Fathers in the First 1000 Days

First Heroes
Start date: August 4, 2020
Phase: N/A
Study type: Interventional

The First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations. This study is a two-arm, randomized controlled trial recruiting from Massachusetts General Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and Pediatric Standard of Care + Safety Control Arm.

NCT ID: NCT04474015 Enrolling by invitation - Sleep Clinical Trials

Optimizing Volunteer Comfort for Transcranial Electrical Stimulation (TES): An Assessment

TES
Start date: May 24, 2014
Phase: N/A
Study type: Interventional

Transcranial electrical stimulation (TES) utilizing weak electrical fields (<5 milliamps of current - as proposed in the present pilot study) is an extremely safe therapeutic technique in use for over 40 years. During that time, TES has never been associated with a serious adverse event in a research setting nor a serious reported adverse event in a clinical setting. The main side effect associated with TES is irritation of the skin beneath the electrodes (as is commonly found from similar preparations used for polysomnography). The purpose of this pilot study is to identify the type of electrode preparation that maximizes subject comfort during transdermal/transcranial electrical stimulation (TES) using the NeuroConn DC Plus Stimulator.

NCT ID: NCT04473222 Completed - Sleep Clinical Trials

Behavioral Sleep Intervention in Urban Primary Care: Aim 3

Start date: October 16, 2020
Phase: N/A
Study type: Interventional

Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude in any change in child sleep and child behavior.

NCT ID: NCT04467372 Completed - Inflammation Clinical Trials

Tart Cherry Supplementation & Gut Microbiome and Inflammation

Start date: March 18, 2019
Phase: N/A
Study type: Interventional

There has been a rapid increase in researching the use of tart cherry supplements in the past 5 years, particularly for inflammatory conditions. Many formulations of cherry supplements exist, however there has been no comparison between these different types. This is particularly important in the realm of inflammation research because sugar is known to increase the inflammatory response. The pill form of cherry supplementation has no added sugar and is naturally low in sugar (< 1g) while the juice form is higher from added sugar. Recent work indicates tart cherry consumption can change gut microbiota, which may modify inflammation. The purpose of this study is to look at the effects of taking a cherry supplement, either in capsule or juice form, on the gut microbiome, inflammation, and health-related variables such as blood pressure, glucose regulation and sleep quality.