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Impact of Sleep Restriction on Performance in Adults

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ClinicalTrials.gov Identifier: NCT02960776
Recruitment Status : Recruiting
First Posted : November 10, 2016
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marie-Pierre St-Onge, Columbia University

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.

Condition or disease Intervention/treatment Phase
Sleep Obesity Sleep Restriction Behavioral: Sleep Restriction (SR) Not Applicable

Detailed Description:

Chronic Sleep Restriction (SR) is highly prevalent in today's modern society. Artificial light, portable electronic devices, and 24-h services have allowed individuals to remain active throughout the night, leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide additional ammunition in the fight to prevent further increases in the incidence of obesity.

This study will be a randomized, crossover, outpatient SR study with 2 phases of 6 weeks each, with a 6 week wash-out period between the phases. Sleep duration in each phase will be the participant's regular bed- and wake times during the habitual sleep (HS) phase and HS minus 1.5 hours in the SR phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. During the SR phase, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Long Term Sleep Restriction on Energy Balance
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
No Intervention: Habitual Sleep (HS)
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.
Experimental: Sleep Restriction (SR)
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)
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.




Primary Outcome Measures :
  1. Change in Fat Mass [ Time Frame: Baseline, Week 6 (endpoint) ]
    Body composition (specifically fat mass) will be measured by MRI at baseline and endpoint.


Secondary Outcome Measures :
  1. Energy Expenditure (EE) [ Time Frame: Weeks 5 and 6 (endpoint) ]
    EE is the amount of energy (or calories) that a person needs to carry out physical functions and will be assessed using Doubly Labeled Water (DLW), during the last 2 weeks of each sleep phase.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960776


Contacts
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Contact: Marie Pierre St-Onge, PhD 212-851-5578 ms2554@cumc.columbia.edu
Contact: Theresa Pizinger, MS 212-851-5173 tmp2125@cumc.columbia.edu

Locations
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United States, New York
New York Nutrition Obesity Research Center Recruiting
New York, New York, United States, 10032
Contact: Marie Pierre St-Onge, PhD    212-851-5578    ms2554@cumc.columbia.edu   
Principal Investigator: Marie Pierre St-Onge, PhD         
Sponsors and Collaborators
Columbia University
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Marie Pierre St-Onge, PhD Columbia University

Publications:
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Responsible Party: Marie-Pierre St-Onge, Associate Professor of Nutritional Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT02960776     History of Changes
Other Study ID Numbers: AAAQ7746
1R01HL128226-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be provided on request after discussion among parties.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After study completion and publication of main findings.
Access Criteria: Contact PI for information
Keywords provided by Marie-Pierre St-Onge, Columbia University:
Body Weight
Habitual sleep