Sleep Extension for Metabolic Health
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|ClinicalTrials.gov Identifier: NCT04467268|
Recruitment Status : Completed
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Short Sleep||Behavioral: Sleep extension||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||18 participants|
|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.|
|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|
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.
- Total sleep time (TST) [ Time Frame: 24 hours ]Time asleep obtained every night, as measured by actigraphy (minutes).
- Time in Bed (TIB) [ Time Frame: 24 hours ]Time between getting into and getting out of bed (minutes)
- Sleep onset latency (SOL) [ Time Frame: 24 hours ]Time to fall asleep (minutes)
- Wake after sleep onset (WASO) [ Time Frame: 24 hours ]Time awake after the first sleep period (minutes)
- 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
- 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
- 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
- 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
- Leptin concentration [ Time Frame: 8-hour fasting blood samples ]Fasting leptin levels
- Minutes per 24 hours of Moderate to vigorous physical activity (MVPA) [ Time Frame: 24 hours ]Physical activity recorded with actigraphs
- 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
- 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
- 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
- Pittsburgh Sleep Quality Index [ Time Frame: One month ]Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.
- 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.
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
|Loughborough, United Kingdom, LE11 3TU|
|Principal Investigator:||Iuliana Hartescu, PhD||Loughborough University|