Sleep Extension for Metabolic Health
- Conditions
- Short Sleep
- Interventions
- Behavioral: Sleep extension
- Registration Number
- NCT04467268
- Lead Sponsor
- Loughborough University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep extension intervention Sleep extension Intervention group participants met with an experienced sleep scientist to discuss and agree changes to their sleep and personal schedules. Discussions lasted 60-90 minutes, were informed by actigraphic sleep assessments from the baseline period, and aimed to increase TST by ≥1 hour/night. The structure and content of the "About Sleep", "Sleep Hygiene" and "Thoughts and Sleep" components of the online Sleepful application, a self-help sleep management programme. Advice was supported by the provision of self-help booklets addressing sleep hygiene and the management of pre-sleep cognitions which had been successfully trailed in an intervention for insomnia symptoms. Finally, to capitalize on the participant's motivation at recruitment, and optimize adherence, the newly agreed sleep schedule was written into an agreement which the participant was asked to sign, simulating a 'therapeutic contract'. Schedules were reviewed by telephone at the end of the first week and revised if required.
- Primary Outcome Measures
Name Time Method Total sleep time (TST) 24 hours Time asleep obtained every night, as measured by actigraphy (minutes).
- Secondary Outcome Measures
Name Time Method Sleep onset latency (SOL) 24 hours Time to fall asleep (minutes)
Time in Bed (TIB) 24 hours Time between getting into and getting out of bed (minutes)
Wake after sleep onset (WASO) 24 hours Time awake after the first sleep period (minutes)
Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose 14 days Obtained from all CGMs 24-hour blood glucose concentrations across the monitoring period with
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 Total area under the PYY concentration curve
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 Total area under the ghrelin concentration curve
Minutes per 24 hours of Moderate to vigorous physical activity (MVPA) 24 hours Physical activity recorded with actigraphs
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 Total area under the insulin concentration curve
Multidimensional Assessment of Fatigue One week Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue.
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 Total area under the glucose concentration curve
Leptin concentration 8-hour fasting blood samples Fasting leptin levels
Mean Amplitude of Glycemic Excursions 24 hours Mean blood glucose values exceeding one standard deviation of the 24-hour arithmetic average across the monitoring period
Systolic and diastolic blood pressure 10 minutes Measurements of arterial blood pressure were taken, each after resting in a supine position for 10 minutes in a fasting state
Pittsburgh Sleep Quality Index One month Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.
Trial Locations
- Locations (1)
Loughborough University
🇬🇧Loughborough, United Kingdom