Sleep Extension for Metabolic Health

Loughborough University

Status: Completed

Conditions: Short Sleep

Treatments: Behavioral: Sleep extension

Study type: Interventional

Funder types: Other

Identifiers

NCT04467268

LBO-SSEHS-SE_IH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Sleep extension intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Sleep extension

Control group

No Intervention group

Description:

Participants in the control group were asked to continue with their habitual sleep schedule.