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Sleep Extension for Metabolic Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467268
Recruitment Status : Completed
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Collaborators:
University Hospitals, Leicester
University of Leicester
Information provided by (Responsible Party):
Dr Iuliana Hartescu, Loughborough University

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.

Condition or disease Intervention/treatment Phase
Short Sleep Behavioral: Sleep extension Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial.
Masking: Single (Outcomes Assessor)
Masking Description: Blood samples outcome assessor was blinded to group allocation.
Primary Purpose: Treatment
Official Title: Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:
Actual Study Start Date : April 15, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : April 15, 2018

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.



Primary Outcome Measures :
  1. Total sleep time (TST) [ Time Frame: 24 hours ]
    Time asleep obtained every night, as measured by actigraphy (minutes).


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467268


Locations
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United Kingdom
Loughborough University
Loughborough, United Kingdom, LE11 3TU
Sponsors and Collaborators
Loughborough University
University Hospitals, Leicester
University of Leicester
Investigators
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Principal Investigator: Iuliana Hartescu, PhD Loughborough University
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Responsible Party: Dr Iuliana Hartescu, Lecturer in Psychology, Loughborough University
ClinicalTrials.gov Identifier: NCT04467268    
Other Study ID Numbers: LBO-SSEHS-SE_IH
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Iuliana Hartescu, Loughborough University:
short sleep
insufficient sleep
sleep extension
diabetes risk