Impact of Sleep Restriction on Performance in Adults

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02960776
Collaborator
NYU Langone Health (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
66
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2
137
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Study Details

Study Description

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
  • Behavioral: Sleep Restriction (SR)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2027
Anticipated Study Completion Date :
Apr 1, 2028

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Fat Mass [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) [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.

  2. Physical activity [6 weeks (measured daily)]

    Time spent in sedentary, light, moderate, and moderate-to-vigoroud physical activity.

  3. Appetite-regulating hormones [Baseline, Week 6 (endpoint)]

    Ghrelin, leptin, glucagon-like peptide 1, orexin, NPY

  4. Neuronal activity [Week 6]

    Neuronal activity at rest and in response to food stimuli

Other Outcome Measures

  1. NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox) [Baseline, Week 6 (endpoint)]

    Measure cognitive, emotional, sensory, and motor functions, raw scores

  2. Neuro-behavioral measures [Baseline, Week 6 (endpoint)]

    ModRey memory task

  3. Immune function [Baseline, Week 6 (endpoint)]

    T-cell stimulation

  4. Immune markers [Baseline, Week 6 (endpoint)]

    White blood cell populations

  5. Activity [Week 5]

    6-minute walk test

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York Nutrition Obesity Research Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University
  • NYU Langone Health
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Marie Pierre St-Onge, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marie-Pierre St-Onge, Associate Professor of Nutritional Medicine, Columbia University
ClinicalTrials.gov Identifier:
NCT02960776
Other Study ID Numbers:
  • AAAQ7746
  • 1R01HL128226-01A1
First Posted:
Nov 10, 2016
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Marie-Pierre St-Onge, Associate Professor of Nutritional Medicine, Columbia University

Study Results

No Results Posted as of Apr 5, 2022