Sleep Clinical Trial - The Sleep Lengthening & Metabolic Health, Body

Status Completed

Clinical Trial Summary

Short sleep duration has been associated with increased risk of weight gain and development of non-communicable diseases. Sleep deprivation studies have suggested the link between restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal. However, the severity and acuteness of sleep restriction schedules in laboratory-based studies could hinder the ecological validity of the findings. The pragmatic way forward is to assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes. This study assesses the feasibility of lengthening sleep in short sleepers, as well as how improved sleep duration and/or quality impact metabolic health, body composition, energy balance and cardiovascular risk.

Clinical Trial Description

Research Questions

- Is it feasible to improve sleep duration and quality in habitually short sleepers under free-living conditions?

- What are the effects of improved sleep duration and quality on body composition, energy balance, dietary intake, and cardio-metabolic risk factors?

Hypothesis

- Improved sleep duration and/or quality in habitually short sleepers will result in improved energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Aims

- To assess the feasibility of improving sleep duration and/or quality in habitually short sleepers using behavioural approaches and public health messages targeting sleep hygiene.

- To identify how improved sleep duration and/or quality affect energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Objectives

1. To develop a sleep extension strategy using behaviour change techniques (BCTs) targeting sleep hygiene.

2. To recruit healthy adults who are habitually short sleepers and randomise eligible participants to an intervention and control group.

3. To assess the feasibility and effectiveness of the intervention.

4. To measure energy balance, diet quality, body composition and cardio-metabolic risk factors pre- and post-treatment in the intervention and control groups.

5. To assess whether the intervention had an effect on the aforementioned parameters by comparing the intervention endpoints to control as well as baseline measures.

6. To run the statistical analysis both on an intention-to-treat basis as well as per-protocol. ;

Study Design

Related Conditions & MeSH terms

Sleep

Clinical Trial Details

NCT number	NCT02787577
Study type	Interventional
Source	King's College London
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	December 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study — SLuMBER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms