The SLuMBER Study: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep
- Sponsor
- King's College London
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Sleep Duration
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and female adults (18-64 years)
- •Habitually short sleepers (5-\<7 hours of sleep per night on average on weekdays) - this is self-reported at screening, and confirmed by actigraphy when baseline measurement is taken.
- •BMI: 18.5 - \<30
Exclusion Criteria
- •Diagnosed medical conditions such as:
- •Cardiovascular disease
- •Type 1 or Type 2 Diabetes Mellitus
- •Cancer (excluding basal carcinoma) in the past five years
- •Chronic renal or liver disease
- •Inflammatory bowel disease
- •Hypo/hyperthyroidism
- •Sleep conditions:
- •Chronic use of sleeping aid medication
- •Insomnia (Insomnia Severity Index - ISI Questionnaire)
Outcomes
Primary Outcomes
Sleep Duration
Time Frame: week 4
Wrist Actigraphy
Sleep Quality
Time Frame: week 4
Wrist Actigraphy
Secondary Outcomes
- Blood pressure(day 28)
- Fasting triglycerides(day 28)
- plasma leptin(day 28)
- plasma cortisol(day 28)
- Fasting blood glucose(day 28)
- Body fat percentage(day 28)
- plasma insulin(day 28)
- Digital volume pulse - Reflection Index (RI)(day 28)
- Dietary Intake (7-day food diary)(week 4)
- Sleep Hygiene Index (SHI)(day 28)
- BMI(day 28)
- Fasting total cholesterol(day 28)
- Fasting HDL cholesterol(day 28)
- plasma ghrelin(day 28)
- Homeostasis model assessment estimated insulin resistance (HOMA-IR)(day 28)
- Waist circumference(day 28)
- Lean body mass(day 28)
- Digital volume pulse - Stiffness Index (SI)(day 28)
- Urinary 6-sulphatoxymelatonin(day 28)
- Recent Physical Activity Questionnaire (RPAQ)(day 28)
- Fasting LDL cholesterol(day 28)
- Hip circumference(day 28)
- Resting Metabolic Rate (RMR)(day 28)
- Mnemonic Similarity Test (MST)(day 28)
- Total Energy Expenditure (TEE)(day 21-23)
- Eating Choices Index (ECI)(day 28)
- Pittsburgh Sleep Quality Index (PSQI)(day 28)