NCT00935402

Brief Summary

Observational and epidemiological studies have found a link between obesity and short sleep duration with the prevalence of both increasing in the past decades. At this time, it is unknown whether short sleep is a cause of obesity and how short sleep would lead to obesity. Some studies associate short sleep with increased levels of hormone that stimulate appetite. This study will examine how food intake and energy expenditure can be modified by sleep duration as a means of understanding a potential causal pathway.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

3 active sites

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

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 23, 2011

Status Verified

May 1, 2010

Enrollment Period

1.7 years

First QC Date

July 8, 2009

Last Update Submit

February 22, 2011

Conditions

Obesity

Keywords

Energy balanceWeight managementFood intakeEnergy expenditure

Outcome Measures

Primary Outcomes (5)

  • Resting metabolic rate

    Day 5 of each arm

  • Food intake

    Days 5-6 of each arm

  • Hormone Measurements

    Daily fasting, and every 2 hours on day 4 of each arm

  • Regional brain activity

    Day 6 of each arm

  • Energy expenditure

    Each 6 day arm

Study Arms (2)

Short Sleep

EXPERIMENTAL

Subjects are permitted to spend 4 hours in bed per night for 5 consecutive nights. Subjects are inpatients for a period of 6 days.

Behavioral: Sleep

Regular Sleep

ACTIVE COMPARATOR

Subjects are permitted to spend 9 hours in bed per night for 5 nights. Subjects are inpatients for a period of 6 days.

Behavioral: Sleep

Interventions

SleepBEHAVIORAL

Subjects are randomly assigned to one of 2 arms sequence: short followed by regular or regular followed by short. Each arm is 6 days in length and separated by a 2-4 week washout period.

Regular SleepShort Sleep

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index 22-25 kg/m2
  • Right-handed
  • Sleep 7-9 hours/night
  • Normal score on Pittsburgh Quality of Sleep questionnaire, Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness

You may not qualify if:

  • Smoker
  • Neurological, medical, or psychiatric disorder
  • Diabetics
  • History of eating disorders
  • Sleep disorders
  • Travel across time zones within 4 weeks of the study
  • History of drug and alcohol abuse
  • Shift worker
  • Caffeine intake \> 300 mg/d
  • Excessive daytime sleepiness
  • Regular napping
  • History of drowsy driving
  • Pregnancy or within 1 y post-partum
  • Heavy equipment operator or commercial long-distance driver
  • Contra-indications for MRI scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinilabs

New York, New York, 10019, United States

Location

St. Luke's/Roosevelt Hospital

New York, New York, 10025, United States

Location

Columbia University

New York, New York, 10036, United States

Location

Related Publications (8)

  • Smith I, Salazar I, RoyChoudhury A, St-Onge MP. Sleep restriction and testosterone concentrations in young healthy males: randomized controlled studies of acute and chronic short sleep. Sleep Health. 2019 Dec;5(6):580-586. doi: 10.1016/j.sleh.2019.07.003. Epub 2019 Aug 12.

    PMID: 31416797DERIVED

  • McNeil J, St-Onge MP. Increased energy intake following sleep restriction in men and women: A one-size-fits-all conclusion? Obesity (Silver Spring). 2017 Jun;25(6):989-992. doi: 10.1002/oby.21831. Epub 2017 Apr 12.

    PMID: 28401667DERIVED

  • St-Onge MP, Roberts A, Shechter A, Choudhury AR. Fiber and Saturated Fat Are Associated with Sleep Arousals and Slow Wave Sleep. J Clin Sleep Med. 2016 Jan;12(1):19-24. doi: 10.5664/jcsm.5384.

    PMID: 26156950DERIVED

  • Shechter A, St-Onge MP. Delayed sleep timing is associated with low levels of free-living physical activity in normal sleeping adults. Sleep Med. 2014 Dec;15(12):1586-9. doi: 10.1016/j.sleep.2014.07.010. Epub 2014 Sep 2.

    PMID: 25311835DERIVED

  • St-Onge MP, Wolfe S, Sy M, Shechter A, Hirsch J. Sleep restriction increases the neuronal response to unhealthy food in normal-weight individuals. Int J Obes (Lond). 2014 Mar;38(3):411-6. doi: 10.1038/ijo.2013.114. Epub 2013 Jun 19.

    PMID: 23779051DERIVED

  • 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: 23115399DERIVED

  • St-Onge MP, McReynolds A, Trivedi ZB, Roberts AL, Sy M, Hirsch J. Sleep restriction leads to increased activation of brain regions sensitive to food stimuli. Am J Clin Nutr. 2012 Apr;95(4):818-24. doi: 10.3945/ajcn.111.027383. Epub 2012 Feb 22.

    PMID: 22357722DERIVED

  • 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: 21715510DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Sleep

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marie-Pierre St-Onge, Ph.D

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 9, 2009

Study Start

November 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 23, 2011

Record last verified: 2010-05

Locations

US(3)