Sleep Extension for Metabolic Health

Short Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467268
• Other study ID #: LBO-SSEHS-SE_IH
• Status: Completed
• Phase: N/A
• Start date: April 15, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: July 2020
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 15, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Short Sleep

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough

Sponsors (3)

Lead Sponsor	Collaborator
Loughborough University	University Hospitals, Leicester, University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep time (TST)	Time asleep obtained every night, as measured by actigraphy (minutes).	24 hours
Secondary	Time in Bed (TIB)	Time between getting into and getting out of bed (minutes)	24 hours
Secondary	Sleep onset latency (SOL)	Time to fall asleep (minutes)	24 hours
Secondary	Wake after sleep onset (WASO)	Time awake after the first sleep period (minutes)	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Leptin concentration	Fasting leptin levels	8-hour fasting blood samples
Secondary	Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)	Physical activity recorded with actigraphs	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Pittsburgh Sleep Quality Index	Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.	One month
Secondary	Multidimensional Assessment of Fatigue	Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue.	One week