NCT02787577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 17, 2019

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

April 5, 2016

Last Update Submit

September 13, 2019

Conditions

Sleep

Keywords

Sleep DurationSleep QualityBody CompositionEnergy IntakeEnergy ExpenditureEnergy BalanceCardiovascular Risk

Outcome Measures

Primary Outcomes (4)

  • Sleep Duration

    Wrist Actigraphy

    baseline

  • Sleep Duration

    Wrist Actigraphy

    week 4

  • Sleep Quality

    Wrist Actigraphy

    baseline

  • Sleep Quality

    Wrist Actigraphy

    week 4

Secondary Outcomes (54)

  • BMI

    baseline

  • BMI

    day 28

  • Body fat percentage

    baseline

  • Body fat percentage

    day 28

  • Blood pressure

    baseline

  • +49 more secondary outcomes

Other Outcomes (3)

  • Dutch Eating Behaviour Questionnaire (DEBQ)

    baseline

  • Women's Health Questionnaire

    baseline

  • Women's Health Questionnaire

    day 21

Study Arms (2)

Sleep Lengthening

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group will be asked to resume their normal lifestyle.

Interventions

Sleep LengtheningBEHAVIORAL

Behaviour change techniques targeting sleep hygiene

Sleep Lengthening

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes & Nutritional Sciences Division, King's College London

London, SE1 9NH, United Kingdom

Location

Related Publications (9)

  • 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.

    PMID: 20054188BACKGROUND

  • 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.

    PMID: 20357041BACKGROUND

  • 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.

    PMID: 20585000BACKGROUND

  • 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.

    PMID: 23479616BACKGROUND

  • 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.

    PMID: 24088722BACKGROUND

  • 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.

    PMID: 10543671BACKGROUND

  • 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.

    PMID: 21715510BACKGROUND

  • 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.

    PMID: 23115399BACKGROUND

  • 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.

    PMID: 29381788DERIVED

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Wendy Hall, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

June 1, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 17, 2019

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)