NCT02960776

Brief Summary

The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 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

November 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 9, 2024

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

6.7 years

First QC Date

November 7, 2016

Results QC Date

March 28, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

Body WeightHabitual sleep

Outcome Measures

Primary Outcomes (1)

  • Endpoint Fat Volume

    Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint.

    Week 6 (endpoint)

Secondary Outcomes (9)

  • Energy Expenditure (EE)

    Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint)

  • Physical Activity

    Average over 6 weeks (measured daily)

  • Ghrelin

    6 weeks

  • Regional Brain Activation in Response to Food Stimuli

    Week 6

  • Sedentary Behavior

    Average over 6 weeks (measured daily)

  • +4 more secondary outcomes

Other Outcomes (5)

  • NIH Toolbox®

    Week 6 (endpoint)

  • Neuro-behavioral Measures

    Week 6 (endpoint)

  • Immune Function

    Week 5 (endpoint)

  • +2 more other outcomes

Study Arms (2)

Habitual Sleep (HS)

NO INTERVENTION

Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.

Sleep Restriction (SR)

EXPERIMENTAL

Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase.

Behavioral: Sleep Restriction (SR)

Interventions

Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.

Sleep Restriction (SR)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 25-29.9 kg/m2
  • Have at least one obese parent
  • Habitually sleep 7-9 hours a night
  • Free of any current and past sleep and psychiatric disorders, including eating disorders, diabetes or Cardiovascular disease (CVD) (i.e., normal scores on: Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire)
  • All racial/ethnic groups

You may not qualify if:

  • Smokers (any cigarettes or ex-smoker \< 3 years)
  • Neurological, medical or psychiatric disorder
  • Diabetics
  • Eating and/or sleep disorders
  • Contraindications for MRI scanning
  • Travel across time zones within 4 weeks
  • History of drug and alcohol abuse
  • Shift worker (or rotating shift worker)
  • Caffeine intake \> 300 mg/d
  • Heavy equipment operators
  • Commercial long-distance drivers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Nutrition Obesity Research Center

New York, New York, 10032, United States

Location

Related Publications (14)

  • Luckhaupt SE, Tak S, Calvert GM. The prevalence of short sleep duration by industry and occupation in the National Health Interview Survey. Sleep. 2010 Feb;33(2):149-59. doi: 10.1093/sleep/33.2.149.

    PMID: 20175398BACKGROUND
  • Keith SW, Redden DT, Katzmarzyk PT, Boggiano MM, Hanlon EC, Benca RM, Ruden D, Pietrobelli A, Barger JL, Fontaine KR, Wang C, Aronne LJ, Wright SM, Baskin M, Dhurandhar NV, Lijoi MC, Grilo CM, DeLuca M, Westfall AO, Allison DB. Putative contributors to the secular increase in obesity: exploring the roads less traveled. Int J Obes (Lond). 2006 Nov;30(11):1585-94. doi: 10.1038/sj.ijo.0803326. Epub 2006 Jun 27.

    PMID: 16801930BACKGROUND
  • Zuraikat FM, Makarem N, Redline S, Aggarwal B, Jelic S, St-Onge MP. Sleep Regularity and Cardiometabolic Heath: Is Variability in Sleep Patterns a Risk Factor for Excess Adiposity and Glycemic Dysregulation? Curr Diab Rep. 2020 Jul 23;20(8):38. doi: 10.1007/s11892-020-01324-w.

    PMID: 32700156BACKGROUND
  • Makarem N, Zuraikat FM, Aggarwal B, Jelic S, St-Onge MP. Variability in Sleep Patterns: an Emerging Risk Factor for Hypertension. Curr Hypertens Rep. 2020 Feb 21;22(2):19. doi: 10.1007/s11906-020-1025-9.

    PMID: 32086595BACKGROUND
  • 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.

  • St-Onge MP, Campbell A, Salazar I, Pizinger T, Liao M, Aggarwal B. Information on Bedtimes and Wake Times Improves the Relation Between Self-Reported and Objective Assessments of Sleep in Adults. J Clin Sleep Med. 2019 Jul 15;15(7):1031-1036. doi: 10.5664/jcsm.7888.

  • Barragan R, Zuraikat FM, Tam V, Scaccia S, Cochran J, Li S, Cheng B, St-Onge MP. Actigraphy-Derived Sleep Is Associated with Eating Behavior Characteristics. Nutrients. 2021 Mar 5;13(3):852. doi: 10.3390/nu13030852.

  • Benasi G, Cheng B, Aggarwal B, St-Onge MP. The effects of sustained mild sleep restriction on stress and distress among healthy adults: Findings from two randomized crossover studies. Sleep Med. 2024 Mar;115:83-87. doi: 10.1016/j.sleep.2024.02.001. Epub 2024 Feb 2.

  • Zimmerman ME, Benasi G, Hale C, Yeung LK, Cochran J, Brickman AM, St-Onge MP. The effects of insufficient sleep and adequate sleep on cognitive function in healthy adults. Sleep Health. 2024 Apr;10(2):229-236. doi: 10.1016/j.sleh.2023.11.011. Epub 2024 Jan 16.

  • Li XY, Yoncheva Y, Yan CG, Castellanos FX, St-Onge MP. Chronic Mild Sleep Restriction Does Not Lead to Marked Neuronal Alterations Compared With Maintained Adequate Sleep in Adults. J Nutr. 2024 Feb;154(2):446-454. doi: 10.1016/j.tjnut.2023.12.016. Epub 2023 Dec 16.

  • Barragan R, Zuraikat FM, Cheng B, Scaccia SE, Cochran J, Aggarwal B, Jelic S, St-Onge MP. Paradoxical Effects of Prolonged Insufficient Sleep on Lipid Profile: A Pooled Analysis of 2 Randomized Trials. J Am Heart Assoc. 2023 Oct 17;12(20):e032078. doi: 10.1161/JAHA.123.032078. Epub 2023 Oct 10.

  • Barragan R, Zuraikat FM, Tam V, RoyChoudhury A, St-Onge MP. Changes in eating patterns in response to chronic insufficient sleep and their associations with diet quality: a randomized trial. J Clin Sleep Med. 2023 Nov 1;19(11):1867-1875. doi: 10.5664/jcsm.10696.

  • McAlpine CS, Kiss MG, Zuraikat FM, Cheek D, Schiroli G, Amatullah H, Huynh P, Bhatti MZ, Wong LP, Yates AG, Poller WC, Mindur JE, Chan CT, Janssen H, Downey J, Singh S, Sadreyev RI, Nahrendorf M, Jeffrey KL, Scadden DT, Naxerova K, St-Onge MP, Swirski FK. Sleep exerts lasting effects on hematopoietic stem cell function and diversity. J Exp Med. 2022 Nov 7;219(11):e20220081. doi: 10.1084/jem.20220081. Epub 2022 Sep 21.

  • Petrov ME, Zuraikat FM, Cheng B, Aggarwal B, Jelic S, Laferrere B, St-Onge MP. Impact of sleep restriction on biomarkers of thyroid function: Two pooled randomized trials. Sleep Med. 2024 Dec;124:606-612. doi: 10.1016/j.sleep.2024.10.035. Epub 2024 Oct 30.

MeSH Terms

Conditions

ObesityBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Marie-Pierre St-Onge
Organization
Columbia University Irving Medical Center

Study Officials

  • Marie-Pierre St-Onge, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Nutritional Medicine

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 10, 2016

Study Start

November 1, 2016

Primary Completion

July 5, 2023

Study Completion

July 5, 2023

Last Updated

April 3, 2025

Results First Posted

July 9, 2024

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

De-identified data will be provided on request after discussion among parties.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After study completion and publication of main findings.
Access Criteria
Contact PI for information

Locations