Sleep Extension for Metabolic Health

NCT ID: NCT04467268

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-15
• Study Completion Date: 2018-04-15

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.

Conditions

Short Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sleep extension intervention

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.

Group Type: EXPERIMENTAL

Sleep extension

Intervention Type: BEHAVIORAL

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: collaborator

Loughborough University

OTHER

Sponsor Role: lead

Responsible Party

Dr Iuliana Hartescu

Lecturer in Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iuliana Hartescu, PhD

Role: PRINCIPAL_INVESTIGATOR

Loughborough University

Locations

Loughborough University

Loughborough, , United Kingdom

Countries

United Kingdom

References

Hartescu I, Stensel DJ, Thackray AE, King JA, Dorling JL, Rogers EN, Hall AP, Brady EM, Davies MJ, Yates T, Morgan K. Sleep extension and metabolic health in male overweight/obese short sleepers: A randomised controlled trial. J Sleep Res. 2022 Apr;31(2):e13469. doi: 10.1111/jsr.13469. Epub 2021 Aug 29.

Reference Type: DERIVED

PMID: 34459060 (View on PubMed)

Other Identifiers

LBO-SSEHS-SE_IH

Identifier Type: -

Identifier Source: org_study_id