Short Sleep
Conditions
Keywords
short sleep, insufficient sleep, sleep extension, diabetes risk
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.
Interventions
BEHAVIORALSleep extension
The sleep extension programme was designed around four alternative assumptions: 1) that among this group of habitual short sleepers, extending time in bed (TIB) would represent a significant behavioral change to established night-time and daytime routines; 2) that for practical purposes (accommodating personal, family and work schedules) extended time in bed is best anchored against typical rise-times; 3) that sleep onset may represent a particular challenge for those advancing habitual bed-times by over 1 hour each night; and 4) that in consenting to the trial, participants were motivated to make and sustain behavioral change.
Sponsors
University Hospitals, Leicester
University of Leicester
Loughborough University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blood samples outcome assessor was blinded to group allocation.
Intervention model description
Randomized controlled trial.
Eligibility
Sex/Gender
MALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total sleep time (TST) | 24 hours | Time asleep obtained every night, as measured by actigraphy (minutes). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep onset latency (SOL) | 24 hours | Time to fall asleep (minutes) |
| Wake after sleep onset (WASO) | 24 hours | Time awake after the first sleep period (minutes) |
| 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 |
| 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 |
| 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 |
| Time in Bed (TIB) | 24 hours | Time between getting into and getting out of bed (minutes) |
| Minutes per 24 hours of Moderate to vigorous physical activity (MVPA) | 24 hours | Physical activity recorded with actigraphs |
| 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 |
| 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. |
| Multidimensional Assessment of Fatigue | One week | Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue. |
| Leptin concentration | 8-hour fasting blood samples | Fasting leptin levels |
Countries
United Kingdom
Outcome results
None listed