NCT01334788

Brief Summary

Chronic sleep deprivation may constitute an important and potentially correctable behavioral factor in the alarming increase in obesity. There are no definitive experimental studies in humans showing whether sleep deprivation indeed contributes to increased energy intake and/or reduced energy expenditure. The investigators propose a series of novel studies to investigate abnormalities in energy homeostasis imparted by sleep deprivation. The investigators will measure food intake, energy expenditure (basal metabolic rate, thermal effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24 healthy subjects with normal BMI (20-25 kg/m2). Twelve subjects (6 men and 6 women) will be randomized to sleep deprivation. Measurements will be compared to those obtained in 12 subjects who are randomized to a control group, and are not sleep deprived. The investigators will test the following hypotheses: 1. That sleep deprivation results in positive energy balance (increased caloric intake and decreased energy expenditure, as reflected by decreased non-exercise activity thermogenesis). 2. That dysregulation of appetite and energy expenditure is associated with changes in molecules controlling appetite and metabolism. 3. That changes associated with 8 days of modest sleep deprivation resolve, at least in part, over a 4 day recovery period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration 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

December 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

October 26, 2010

Last Update Submit

May 11, 2023

Conditions

Keywords

sleep deprivationsleep restriction

Outcome Measures

Primary Outcomes (1)

  • Sleep Deprivation results in positive energy balance

    The investigators are testing the hypothesis that sleep deprivation results in increased caloric intake (calories from food consumed) and reduced energy expenditure (calories burned), resulting in a net positive energy balance.

    15 days

Study Arms (2)

sleep deprivation

EXPERIMENTAL

These are subjects who are randomized to undergo sleep deprivation.

Other: sleep deprivation

Normal sleep

OTHER

These are subjects who are randomized to sleep normally.

Other: Normal sleep

Interventions

Sleep restriction

Also known as: sleep restriction
sleep deprivation

These are subjects who are randomized to sleep normally.

Also known as: control
Normal sleep

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects will be sedentary. Sedentary will be defined as those with an occupational calorie expenditure that is not estimated at greater than 50% above basal (desk job or light activity at work: on feet 30-50% of the work day) and whose exercise activity is defined as sedentary according to a self-reported activity questionnaire, and confirmed by actigraphy measurements. Sedentary lifestyle will be defined as fewer than four 20 min episodes of moderate or vigorous intensity activity in the previous four weeks.

You may not qualify if:

  • We will exclude subjects who have any medical or psychiatric disorders, including history of anxiety or depression, and those taking any medications.
  • Those found to have depression on a depression screening tool (BDI-II) will be excluded.
  • Current smokers will be excluded.
  • All female subjects will undergoing a screening pregnancy test and excluded if positive.
  • Subjects found to have significant sleep disorders will be excluded. -
  • Subjects found to have occult coronary artery disease by exercise treadmill testing will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Calvin AD, Covassin N, Kremers WK, Adachi T, Macedo P, Albuquerque FN, Bukartyk J, Davison DE, Levine JA, Singh P, Wang S, Somers VK. Experimental sleep restriction causes endothelial dysfunction in healthy humans. J Am Heart Assoc. 2014 Nov 25;3(6):e001143. doi: 10.1161/JAHA.114.001143.

  • Calvin AD, Carter RE, Adachi T, Macedo PG, Albuquerque FN, van der Walt C, Bukartyk J, Davison DE, Levine JA, Somers VK. Effects of experimental sleep restriction on caloric intake and activity energy expenditure. Chest. 2013 Jul;144(1):79-86. doi: 10.1378/chest.12-2829.

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Erik K St Louis, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 26, 2010

First Posted

April 13, 2011

Study Start

December 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations