Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Short Sleep
- Sponsor
- Loughborough University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Total sleep time (TST)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The study aims to examine the effects of a sleep extension intervention on the metabolic and cardio-vascular profile of obese people who present traditional diabetes risk factors, and who are habitually sleep deprived. Participants randomized to the intervention arm will complete a 6-week sleep extension intervention, whilst the control group will maintain their habitual sleep schedule. It is hypothesized that the sleep extension intervention will significantly increase total sleep time, and will be accompanied by significant metabolic-related changes.
Detailed Description
Recent epidemiological (survey) research, conducted in both in healthy populations and among those with existing chronic disease, shows that insufficient sleep can significantly contribute to ill health (including diabetes, heart disease and obesity). These findings have also been accompanied by credible explanatory mechanisms emphasising the role of sleep in regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a largely unexplored pathway for improving individual health, and reducing an existing risk of diabetes. If successful, increased sleep duration and quality could be adopted as an achievable public health intervention. The study aims to recruit a total of 20 men, overweight, presenting traditional risks of developing diabetes, who are habitually short sleepers. Participants are then randomized, stratified by weight status, to a sleep extension group, or a control sleep monitoring group. Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure, and a mixed-meal tolerance test; after the 6-week intervention, the same measures are repeated.
Investigators
Dr Iuliana Hartescu
Lecturer in Psychology
Loughborough University
Eligibility Criteria
Inclusion Criteria
- •Age: 25 to 55 years (inclusive)
- •Gender: Men
- •BMI \> 25kg/m2
- •Average self-reported sleep duration of ≤ 6h per 24h
- •Stable daily sleep/wake schedule
- •Health risk screening score ≥ 2
Exclusion Criteria
- •Diagnosed sleep disorder as per DSM-5: e.g. insomnia, restless legs syndrome, moderate/severe Obstructive Sleep Apnoea; Epworth Sleepiness Score: \<5
- •Diagnosed chronic conditions, or medication, likely to interfere with regular sleep: T2D, chronic fatigue syndrome, fibromyalgia, COPD, uncontrolled depression/anxiety, other severe psychiatric illness, substance abuse.
- •Night/evening shift work , regular time-zone travel, other circumstances preventing regular sleep schedule (e.g. very young children, carer at night for sick relatives etc)
Outcomes
Primary Outcomes
Total sleep time (TST)
Time Frame: 24 hours
Time asleep obtained every night, as measured by actigraphy (minutes).
Secondary Outcomes
- Sleep onset latency (SOL)(24 hours)
- Time in Bed (TIB)(24 hours)
- Wake after sleep onset (WASO)(24 hours)
- Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose(14 days)
- Total PYY concentration(3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes)
- Grelin concentration(3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes)
- Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)(24 hours)
- Insulin concentration(3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes)
- Multidimensional Assessment of Fatigue(One week)
- Glucose concentration(3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes)
- Leptin concentration(8-hour fasting blood samples)
- Mean Amplitude of Glycemic Excursions(24 hours)
- Systolic and diastolic blood pressure(10 minutes)
- Pittsburgh Sleep Quality Index(One month)