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Completed

NCT Number: NCT04467268

Sleep Extension for Metabolic Health

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.

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Key information

Age range

25 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, LE11 3TU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Total sleep time (TST)

    Time frame: 24 hours

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

Secondary outcomes

  1. Time in Bed (TIB)

    Time frame: 24 hours

    Time between getting into and getting out of bed (minutes)

  2. Sleep onset latency (SOL)

    Time frame: 24 hours

    Time to fall asleep (minutes)

  3. Wake after sleep onset (WASO)

    Time frame: 24 hours

    Time awake after the first sleep period (minutes)

  4. Glucose concentration

    Time frame: 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

  5. Insulin concentration

    Time frame: 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

  6. Total PYY concentration

    Time frame: 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

  7. Grelin concentration

    Time frame: 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

  8. Leptin concentration

    Time frame: 8-hour fasting blood samples

    Fasting leptin levels

  9. Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)

    Time frame: 24 hours

    Physical activity recorded with actigraphs

  10. Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose

    Time frame: 14 days

    Obtained from all CGMs 24-hour blood glucose concentrations across the monitoring period with

  11. Mean Amplitude of Glycemic Excursions

    Time frame: 24 hours

    Mean blood glucose values exceeding one standard deviation of the 24-hour arithmetic average across the monitoring period

  12. Systolic and diastolic blood pressure

    Time frame: 10 minutes

    Measurements of arterial blood pressure were taken, each after resting in a supine position for 10 minutes in a fasting state

  13. Pittsburgh Sleep Quality Index

    Time frame: One month

    Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.

  14. Multidimensional Assessment of Fatigue

    Time frame: One week

    Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue.

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Collaborators

  • University Hospitals, Leicester
  • University of Leicester

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2020
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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