The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study (SLuMBER)

The SLuMBER Study: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study

Short sleep duration has been associated with increased risk of weight gain and development of non-communicable diseases. Sleep deprivation studies have suggested the link between restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal. However, the severity and acuteness of sleep restriction schedules in laboratory-based studies could hinder the ecological validity of the findings. The pragmatic way forward is to assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes. This study assesses the feasibility of lengthening sleep in short sleepers, as well as how improved sleep duration and/or quality impact metabolic health, body composition, energy balance and cardiovascular risk.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Sleep Lengthening

Detailed Description

Research Questions

• Is it feasible to improve sleep duration and quality in habitually short sleepers under free-living conditions?
• What are the effects of improved sleep duration and quality on body composition, energy balance, dietary intake, and cardio-metabolic risk factors?

Hypothesis

- Improved sleep duration and/or quality in habitually short sleepers will result in improved energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Aims

• To assess the feasibility of improving sleep duration and/or quality in habitually short sleepers using behavioural approaches and public health messages targeting sleep hygiene.
• To identify how improved sleep duration and/or quality affect energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Objectives

1. To develop a sleep extension strategy using behaviour change techniques (BCTs) targeting sleep hygiene.
2. To recruit healthy adults who are habitually short sleepers and randomise eligible participants to an intervention and control group.
3. To assess the feasibility and effectiveness of the intervention.
4. To measure energy balance, diet quality, body composition and cardio-metabolic risk factors pre- and post-treatment in the intervention and control groups.
5. To assess whether the intervention had an effect on the aforementioned parameters by comparing the intervention endpoints to control as well as baseline measures.
6. To run the statistical analysis both on an intention-to-treat basis as well as per-protocol.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Diabetes & Nutritional Sciences Division, King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female adults (18-64 years)
• Habitually short sleepers (5-<7 hours of sleep per night on average on weekdays) - this is self-reported at screening, and confirmed by actigraphy when baseline measurement is taken.
• BMI: 18.5 - <30

Exclusion Criteria:

• Diagnosed medical conditions such as:
• Cardiovascular disease
• Type 1 or Type 2 Diabetes Mellitus
• Cancer (excluding basal carcinoma) in the past five years
• Chronic renal or liver disease
• Inflammatory bowel disease
• Hypo/hyperthyroidism
• Sleep conditions:
• Chronic use of sleeping aid medication
• Insomnia (Insomnia Severity Index - ISI Questionnaire)
• Sleep apnoea (Berlin Questionnaire)
• Extreme Chronotype (HorneOstberg questionnaire)
• Pregnancy or lactation
• Weight change of >3 kg in the previous two months
• Previous or current high alcohol intake (>28 units/week for males and >21 units/week for females) or substance abuse
• Smoking
• Working hours outside 7 am - 7 pm
• Habitual napping (>20 minutes per day on a regular basis)
• Obliged to wake and care for family/friends (e.g. new born child etc)
• Use of antidepressants
• Depressed mood (Center of Epidemiologic Studies of Depression 20-item scale questionnaire)
• Travel arrangements outside time zone within the periods of data collection
• Travel arrangements outside time zone within period of intervention/control condition
• Inability to adhere to a sleep hygiene intervention/sleep schedule due to time commitments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Lengthening; The intervention group will receive a personalised sleep consultation session to lengthen sleep by 1-1.5 hours per night by targeting sleep hygiene using behaviour change techniques for 4 weeks.	Behavioral: Sleep Lengthening; Behaviour change techniques targeting sleep hygiene
No Intervention: Control; The control group will be asked to resume their normal lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Duration	Wrist Actigraphy	baseline
Sleep Duration	Wrist Actigraphy	week 4
Sleep Quality	Wrist Actigraphy	baseline
Sleep Quality	Wrist Actigraphy	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI		baseline
BMI		day 28
Body fat percentage		baseline
Body fat percentage		day 28
Blood pressure		baseline
Blood pressure		day 28
Fasting blood glucose		baseline
Fasting blood glucose		day 28
Fasting total cholesterol		baseline
Fasting HDL cholesterol		baseline
Fasting LDL cholesterol		baseline
Fasting triglycerides		baseline
Fasting total cholesterol		day 28
Fasting HDL cholesterol		day 28
Fasting LDL cholesterol		day 28
Fasting triglycerides		day 28
plasma leptin		baseline
plasma leptin		day 28
plasma ghrelin		baseline
plasma ghrelin		day 28
plasma insulin		baseline
plasma insulin		day 28
plasma cortisol		baseline
plasma cortisol		day 28
Homeostasis model assessment estimated insulin resistance (HOMA-IR)		baseline
Homeostasis model assessment estimated insulin resistance (HOMA-IR)		day 28
Waist circumference		baseline
Waist circumference		day 28
Hip circumference		baseline
Hip circumference		day 28
Lean body mass		baseline
Lean body mass		day 28
Digital volume pulse - Stiffness Index (SI)		baseline
Digital volume pulse - Stiffness Index (SI)		day 28
Digital volume pulse - Reflection Index (RI)		baseline
Digital volume pulse - Reflection Index (RI)		day 28
Mnemonic Similarity Test (MST)		baseline
Mnemonic Similarity Test (MST)		day 28
Dietary Intake (7-day food diary)		baseline
Dietary Intake (7-day food diary)		week 4
Resting Metabolic Rate (RMR)		baseline
Resting Metabolic Rate (RMR)		day 28
Total Energy Expenditure (TEE)		baseline
Total Energy Expenditure (TEE)		day 21-23
Urinary 6-sulphatoxymelatonin	Analysed from spot urine sample	baseline
Urinary 6-sulphatoxymelatonin	Analysed from spot urine sample	day 28
Recent Physical Activity Questionnaire (RPAQ)		baseline
Recent Physical Activity Questionnaire (RPAQ)		day 28
Sleep Hygiene Index (SHI)		baseline
Sleep Hygiene Index (SHI)		day 28
Eating Choices Index (ECI)		baseline
Eating Choices Index (ECI)		day 28
Pittsburgh Sleep Quality Index (PSQI)		baseline
Pittsburgh Sleep Quality Index (PSQI)		day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dutch Eating Behaviour Questionnaire (DEBQ)		baseline
Women's Health Questionnaire	Questionnaire to identify menstrual phase	baseline
Women's Health Questionnaire	Questionnaire to identify menstrual phase	day 21

Collaborators and Investigators

• Sponsor: King's College London

Publications and helpful links

General Publications

• Bosy-Westphal A, Hinrichs S, Jauch-Chara K, Hitze B, Later W, Wilms B, Settler U, Peters A, Kiosz D, Muller MJ. Influence of partial sleep deprivation on energy balance and insulin sensitivity in healthy women. Obes Facts. 2008;1(5):266-73. doi: 10.1159/000158874. Epub 2008 Oct 23.
• Brondel L, Romer MA, Nougues PM, Touyarou P, Davenne D. Acute partial sleep deprivation increases food intake in healthy men. Am J Clin Nutr. 2010 Jun;91(6):1550-9. doi: 10.3945/ajcn.2009.28523. Epub 2010 Mar 31.
• Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28.
• Markwald RR, Melanson EL, Smith MR, Higgins J, Perreault L, Eckel RH, Wright KP Jr. Impact of insufficient sleep on total daily energy expenditure, food intake, and weight gain. Proc Natl Acad Sci U S A. 2013 Apr 2;110(14):5695-700. doi: 10.1073/pnas.1216951110. Epub 2013 Mar 11.
• Shechter A, Rising R, Albu JB, St-Onge MP. Experimental sleep curtailment causes wake-dependent increases in 24-h energy expenditure as measured by whole-room indirect calorimetry. Am J Clin Nutr. 2013 Dec;98(6):1433-9. doi: 10.3945/ajcn.113.069427. Epub 2013 Oct 2.
• Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. doi: 10.1016/S0140-6736(99)01376-8.
• St-Onge MP, Roberts AL, Chen J, Kelleman M, O'Keeffe M, RoyChoudhury A, Jones PJ. Short sleep duration increases energy intakes but does not change energy expenditure in normal-weight individuals. Am J Clin Nutr. 2011 Aug;94(2):410-6. doi: 10.3945/ajcn.111.013904. Epub 2011 Jun 29.
• St-Onge MP, O'Keeffe M, Roberts AL, RoyChoudhury A, Laferrere B. Short sleep duration, glucose dysregulation and hormonal regulation of appetite in men and women. Sleep. 2012 Nov 1;35(11):1503-10. doi: 10.5665/sleep.2198.
• Al Khatib HK, Hall WL, Creedon A, Ooi E, Masri T, McGowan L, Harding SV, Darzi J, Pot GK. Sleep extension is a feasible lifestyle intervention in free-living adults who are habitually short sleepers: a potential strategy for decreasing intake of free sugars? A randomized controlled pilot study. Am J Clin Nutr. 2018 Jan 1;107(1):43-53. doi: 10.1093/ajcn/nqx030. Erratum In: Am J Clin Nutr. 2018 Apr 1;107(4):676.

Helpful Links

• Primary publication

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Body Composition; Sleep Quality; Energy Expenditure; Cardiovascular Risk; Energy Intake; Energy Balance; Sleep Duration
• Other Study ID Numbers: SLuMBER Study 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No