Sleep Extension for Metabolic Health

NCT04467268 | Completed

• 1 other identifier: LBO-SSEHS-SE_IH
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Sleep

Keywords

short sleep; insufficient sleep; sleep extension; diabetes risk

Outcome Measures

Primary Outcomes (1)

• Total sleep time (TST)

  Time asleep obtained every night, as measured by actigraphy (minutes).

  24 hours

Secondary Outcomes (14)

• Time in Bed (TIB)

  24 hours

• Sleep onset latency (SOL)

  24 hours

• Wake after sleep onset (WASO)

  24 hours

• 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

• 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

Study Arms (2)

Sleep extension intervention

EXPERIMENTAL

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.

Behavioral: Sleep extension

Control group

NO INTERVENTION

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

Interventions

Sleep extension 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.

Sleep extension intervention

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loughborough University: lead
• University Hospitals, Leicester: collaborator
• University of Leicester: collaborator

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34459060 DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Iuliana Hartescu, PhD

  Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blood samples outcome assessor was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Psychology

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: April 15, 2017
• Primary Completion: April 15, 2018
• Study Completion: April 15, 2018
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)