Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Protecting Health In Later Life

This study has been completed.
Information provided by:
University of Pittsburgh Identifier:
First received: September 12, 2005
Last updated: June 1, 2006
Last verified: June 2006

The purpose of this study is to see whether protecting sleep quality in later life is important in continued healthy aging. The value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on sleep quality, health, and well being.

Condition Intervention
Health Promotion
Behavioral: Modest sleep deprivation with sleep hygiene education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Polysomnographic measures of sleep consolidation, sleep depth and daytime sleepiness at baseline, 6mos.,12mos., 18mos.,30 mons.

Secondary Outcome Measures:
  • Clinical measures of sleep quality, general functioning, mental health at baseline,6 mos., 12 mons., 18mons.,30mons.

Estimated Enrollment: 66
Study Start Date: June 2003
Detailed Description:

The goal of this project is to test the efficacy of restricting time in bed and education in healthy sleep practices for maintaining or even enhancing sleep consolidation and depth in subjects aged 75+ who are at risk for decay in sleep quality and daytime well being; to determine the associated benefits for health; and to examine the persistence of such effects for 12 months beyond the end of the 18-month intervention. This project focuses not on pathology but on prevention of sleep decay and preservation of sleep in individuals who have already evidenced successful aging.


Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • age 75 or older
  • without sleep disorders
  • without psychiatric disorders
  • Folstein MMSE of 24 or greater

Exclusion Criteria:

  • Apnea-hypopnea index greater than 30
  • Mean sleep latency less than 6
  • Psychotropic medications present
  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 identifier: NCT00177385

Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Charles F. Reynolds lll, M.D. University of Pittsburgh
  More Information

Additional Information:
No publications provided Identifier: NCT00177385     History of Changes
Other Study ID Numbers: IRB #021116, AW-AG20677
Study First Received: September 12, 2005
Last Updated: June 1, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Sleep Hygiene
Modest sleep deprivation
Healthy Aging and sleep
Health Promotion processed this record on March 03, 2015