Sleep Extension for Metabolic Health

Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:

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.

Study Overview

• Status: Completed
• Conditions: Short Sleep
• Intervention / Treatment: Behavioral: Sleep extension

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Loughborough, United Kingdom, LE11 3TU
    • Loughborough University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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.
NO_INTERVENTION: Control group; Participants in the control group were asked to continue with their habitual sleep schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time (TST)	Time asleep obtained every night, as measured by actigraphy (minutes).	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Bed (TIB)	Time between getting into and getting out of bed (minutes)	24 hours
Sleep onset latency (SOL)	Time to fall asleep (minutes)	24 hours
Wake after sleep onset (WASO)	Time awake after the first sleep period (minutes)	24 hours
Glucose concentration	Total area under the glucose concentration curve	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	Total area under the insulin concentration curve	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 PYY concentration	Total area under the PYY concentration curve	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
Grelin concentration	Total area under the ghrelin concentration curve	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
Leptin concentration	Fasting leptin levels	8-hour fasting blood samples
Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)	Physical activity recorded with actigraphs	24 hours
Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose	Obtained from all CGMs 24-hour blood glucose concentrations across the monitoring period with	14 days
Mean Amplitude of Glycemic Excursions	Mean blood glucose values exceeding one standard deviation of the 24-hour arithmetic average across the monitoring period	24 hours
Systolic and diastolic blood pressure	Measurements of arterial blood pressure were taken, each after resting in a supine position for 10 minutes in a fasting state	10 minutes
Pittsburgh Sleep Quality Index	Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.	One month
Multidimensional Assessment of Fatigue	Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue.	One week

Collaborators and Investigators

• Sponsor: Loughborough University
• Collaborators: University Hospitals, Leicester; University of Leicester
• Investigators: Principal Investigator: Iuliana Hartescu, PhD, Loughborough University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2017
• Primary Completion (ACTUAL): April 15, 2018
• Study Completion (ACTUAL): April 15, 2018

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (ACTUAL): July 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: diabetes risk; sleep extension; insufficient sleep; short sleep
• Other Study ID Numbers: LBO-SSEHS-SE_IH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No