Effects of Chronic Sleep Restriction in Young and Older People

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00506428
First received: April 27, 2007
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to examine the consequences of chronic sleep restriction on nighttime sleep, daytime alertness, performance and memory functions, and metabolic and cardiovascular function, and to determine if the consequences of chronic sleep restriction differ between healthy young and older adults.


Condition Intervention
Aging
Sleep Deprivation
Metabolic Syndrome
Behavioral: chronic sleep restriction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Sleep, Aging, and Circadian Rhythm Disorders

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes in sleep and waking EEG measures [ Time Frame: During 3-week chronic sleep restriction segment of inpatient study ] [ Designated as safety issue: No ]
  • frequent measures of performance, attention, alertness, and memory [ Time Frame: During 3-week chronic sleep restriction segment of inpatient study ] [ Designated as safety issue: No ]
  • measures of cardiovascular and metabolic function [ Time Frame: During 3-week chronic sleep restriction segment of inpatient study ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: chronic sleep restriction
    5.6 hours of sleep per 24 hours for 3 weeks
Detailed Description:

It has long been recognized that sleep patterns change with age. A common feature of aging is the advance of the timing of sleep to earlier hours, often earlier than desired. Polysomnographically-recorded sleep in older people shows an increased number of awakenings, a reduction of stages 3 and 4 (SWS) sleep, and a flattening of REM sleep distribution throughout the night. These age-related changes are found in even healthy individuals who are not taking medications and who are free from sleep disorders. In addition to these sleep disturbances, many older individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction (sleeping less than 7 or less than 6 hours per night) as young adults. Whether voluntary or not, insufficient sleep has medical, safety and metabolic consequences. In fact, converging evidence in young adults suggests that sleep restriction per se may impair metabolism, and that reduced sleep duration is associated with weight gain, obesity, diabetes, cardiovascular disease, and mortality.

The study begins with 21 days of outpatient study in which the participants will be required to sleep for 10 hours each night in order to ensure they are well-rested. This will be followed by a 39-day inpatient study. The study will begin with 3 "sleep satiation" days during which all participants will be scheduled to sleep for 12 hours per night and have a 4 hour nap each afternoon. This is followed by 3 baseline days in which the participants will follow the same sleep-wake schedule they were following at home. Following this, the participant will undergo 3 weeks of chronic sleep restriction while living on a non-24-hour schedule. The participant will live on a schedule that is equivalent to 5.6 hours of sleep per 24 hours. Following these 3 weeks, the participant will be scheduled to again sleep for 10 hours per night for 10 nights.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Chronic or acute medical condition
  • Medication use
  • Depression
  • History of psychiatric illness
  • Sleep disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506428

Locations
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Tomoko Okada    617-732-7991    sleepstudy@partners.org   
Contact: Sean W Cain, PhD    617-732-5174    swcain@rics.bwh.harvard.edu   
Principal Investigator: Charles A Czeisler, PhD, MD         
Sub-Investigator: Jeanne F Duffy, PhD         
Sub-Investigator: Sean W Cain, PhD         
Sub-Investigator: Orfeu M Buxton, PhD         
Sub-Investigator: Mirjam Munch, PhD         
Sub-Investigator: Daniel Aeschbach, PhD         
Sub-Investigator: Elizabeth B Klerman, MD, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Charles A Czeisler, PhD, MD Brigham and Women's Hospital
  More Information

Publications:

Responsible Party: Charles A Czeisler, PhD, MD, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00506428     History of Changes
Other Study ID Numbers: AG0077, 2P01AG009975-11
Study First Received: April 27, 2007
Last Updated: April 28, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute on Aging (NIA):
aging
sleep
sleep deprivation
performance
memory
metabolism

Additional relevant MeSH terms:
Metabolic Syndrome X
Sleep Deprivation
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014