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

Sleep Clinical Trial

— SLuMBER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787577
• Other study ID #: SLuMBER Study 2016
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Sleep Lengthening
Behaviour change techniques targeting sleep hygiene

Locations

Country	Name	City	State
United Kingdom	Diabetes & Nutritional Sciences Division, King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. — View Citation

St-Onge MP, O'Keeffe M, Roberts AL, RoyChoudhury A, Laferrère 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. — View Citation

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. — View Citation

Outcome

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

External Links

•   Primary publication