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Completed

NCT Number: NCT02960776

Impact of Sleep Restriction on Performance in Adults

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.

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Key information

Conditions

Sleep Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Restriction

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Nutrition Obesity Research Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Restriction (SR)

Behavioral

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 outcomes

  1. Endpoint Fat Volume

    Time frame: Week 6 (endpoint)

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

Secondary outcomes

  1. 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.

  2. Physical Activity

    Time frame: Average over 6 weeks (measured daily)

    Time spent in moderate-to-vigorous physical activity.

  3. Ghrelin

    Time frame: 6 weeks

    Average post-baseline values

  4. 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.

  5. Sedentary Behavior

    Time frame: Average over 6 weeks (measured daily)

    Time spent in sedentary physical activity.

  6. Leptin

    Time frame: 6 weeks

    Average post-baseline values

  7. Glucagon-like Peptide 1

    Time frame: 6 weeks

    Average post-baseline values

  8. Orexin

    Time frame: 6 weeks

    Average post-baseline values

  9. Neuropeptide Y

    Time frame: 6 weeks

    Average post-baseline values

Other outcomes

  1. 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.

  2. 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.

  3. Immune Function

    Time frame: Week 5 (endpoint)

    CD8+ T-cells from samples collected late in the day (non-fasted)

  4. Immune Markers

    Time frame: Week 5 (endpoint)

    Classical monocytes measured from samples collected late in the day (non-fasted)

  5. Distance Walked

    Time frame: Week 5

    Distance walked over a 6-minute walk test

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

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

Registry information

Official study title

Effect of Long Term Sleep Restriction on Energy Balance

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Nov 10, 2016
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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