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

• ClinicalTrials.gov Identifier: NCT02787577
• Recruitment Status: Completed
• First Posted: June 1, 2016
• Last Update Posted: September 17, 2019
• Sponsor: King's College London
• Information provided by (Responsible Party): King's College London

Tracking Information

• First Submitted Date: April 5, 2016
• First Posted Date: June 1, 2016
• Last Update Posted Date: September 17, 2019
• Study Start Date: April 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2016)

• Sleep Duration [ Time Frame: baseline ]
  Wrist Actigraphy
• Sleep Duration [ Time Frame: week 4 ]
  Wrist Actigraphy
• Sleep Quality [ Time Frame: baseline ]
  Wrist Actigraphy
• Sleep Quality [ Time Frame: week 4 ]
  Wrist Actigraphy

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02787577 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 27, 2016)

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 27, 2016)

• Dutch Eating Behaviour Questionnaire (DEBQ) [ Time Frame: baseline ]
• Women's Health Questionnaire [ Time Frame: baseline ]
  Questionnaire to identify menstrual phase
• Women's Health Questionnaire [ Time Frame: day 21 ]
  Questionnaire to identify menstrual phase

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study
• Official Title: The SLuMBER Study: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study
• Brief 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Sleep

Intervention

Behavioral: Sleep Lengthening

Behaviour change techniques targeting sleep hygiene

Study Arms

• 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.
  Intervention: Behavioral: Sleep Lengthening
• No Intervention: Control
  The control group will be asked to resume their normal lifestyle.

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.
• 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, 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 8, 2016): 43
• Original Estimated Enrollment (submitted: May 27, 2016): 40
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02787577
• Other Study ID Numbers: SLuMBER Study 2016
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: King's College London
• Study Sponsor: King's College London
• Collaborators: Not Provided

Investigators

• Principal Investigator: Wendy Hall, PhD; King's College London

• PRS Account: King's College London
• Verification Date: June 2016