Impact of Sleep Restriction on Performance in Adults

March 26, 2025 updated by: Marie-Pierre St-Onge, Columbia University

Effect of Long Term Sleep Restriction on Energy Balance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Nutrition Obesity Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endpoint Fat Volume
Time Frame: Week 6 (endpoint)
Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint.
Week 6 (endpoint)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy Expenditure (EE)
Time Frame: Measured over 14 days at the end of each phase (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.
Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint)
Physical Activity
Time Frame: Average over 6 weeks (measured daily)
Time spent in moderate-to-vigorous physical activity.
Average over 6 weeks (measured daily)
Ghrelin
Time Frame: 6 weeks
Average post-baseline values
6 weeks
Sedentary Behavior
Time Frame: Average over 6 weeks (measured daily)
Time spent in sedentary physical activity.
Average over 6 weeks (measured daily)
Leptin
Time Frame: 6 weeks
Average post-baseline values
6 weeks
Glucagon-like Peptide 1
Time Frame: 6 weeks
Average post-baseline values
6 weeks
Orexin
Time Frame: 6 weeks
Average post-baseline values
6 weeks
Neuropeptide Y
Time Frame: 6 weeks
Average post-baseline values
6 weeks
Regional Brain Activation in Response to Food Stimuli
Time Frame: Week 6

The primary aim of this outcome was to investigate brain activation in response to food stimuli after a six-week period of Adequate Sleep (AS) or mild Sleep Restriction (SR). To achieve this, the investigators contrasted neuronal responses to food and non-food stimuli at two time points (baseline and six weeks post-intervention/control). This contrast allowed the investigators to calculate the number of voxels activated during the view of food stimuli compared to the number of voxels activated during the view of non-food stimuli (food - non-food) under each condition (AS or SR).

Regional brain activation is reported as the total number of voxels activated on the group contrast images (combination of all analyzed participants) of the neuronal response to food stimuli compared to non-food stimuli. For this analysis, voxels were considered activated if they survived Gaussian Random Field theory correction with a 2-tailed p < 0.001 threshold when creating the group contrast images.
Week 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIH Toolbox®
Time Frame: Week 6 (endpoint)
Working memory data were collected using the List Sorting Working Memory Test from the NIH Toolbox. Data were transformed into a t-score ranging from 0-100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data were collected at baseline and after 6 weeks on study intervention. Traditionally, a clinically relevant threshold for cognitive data is 1.5 standard deviations below the mean. For a t-score, this would mean that a score of 35 or lower suggests clinical relevance.
Week 6 (endpoint)
Neuro-behavioral Measures
Time Frame: Week 6 (endpoint)
Episodic verbal learning and memory were collected using the Modified Rey Auditory Verbal Learning Test (ModRey). The primary variable of interest for this test is the number of correctly recalled words across three learning trials from List A consisting of 20 words in each trial. The total score range across three trials is 0-60. A higher score indicates better performance.
Week 6 (endpoint)
Immune Function
Time Frame: Week 5 (endpoint)
CD8+ T-cells from samples collected late in the day (non-fasted)
Week 5 (endpoint)
Immune Markers
Time Frame: Week 5 (endpoint)
Classical monocytes measured from samples collected late in the day (non-fasted)
Week 5 (endpoint)
Distance Walked
Time Frame: Week 5
Distance walked over a 6-minute walk test
Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimated)

November 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAQ7746
  • 1R01HL128226-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

After study completion and publication of main findings.

IPD Sharing Access Criteria

Contact PI for information

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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