Clinical trial NCT04467268: Sleep Extension for Metabolic Health
Official title: Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Sleep
Keywords: short sleep
insufficient sleep
sleep extension
diabetes risk
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
name: University of Leicester
First posted: 2020-07-10
Enrollment: 18
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial.
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Total sleep time (TST)
timeFrame: 24 hours
Secondary outcomes:
measure: Time in Bed (TIB)
timeFrame: 24 hours
measure: Sleep onset latency (SOL)
timeFrame: 24 hours
measure: Wake after sleep onset (WASO)
timeFrame: 24 hours
measure: Glucose concentration
timeFrame: 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
measure: Insulin concentration
timeFrame: 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
measure: Total PYY concentration
timeFrame: 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
measure: Grelin concentration
timeFrame: 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
measure: Leptin concentration
timeFrame: 8-hour fasting blood samples
measure: Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)
timeFrame: 24 hours
measure: Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose
timeFrame: 14 days
measure: Mean Amplitude of Glycemic Excursions
timeFrame: 24 hours
measure: Systolic and diastolic blood pressure
timeFrame: 10 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: One month
measure: Multidimensional Assessment of Fatigue
timeFrame: One week
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
Study officials:
affiliation: Loughborough University
name: Iuliana Hartescu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.