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Aging Well, Sleeping Efficiently: Protecting Health In Later Life (AgeWise)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00177385
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Health Promotion Behavioral: Modest sleep deprivation with sleep hygiene education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: AGEWISE Project 4: PROTECTING HEALTH IN LATER LIFE
Study Start Date : June 2003
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2011



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177385


Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Charles F. Reynolds lll, M.D. University of Pittsburgh Medical Center
Additional Information:
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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177385    
Other Study ID Numbers: IRB #021116
5P01AG020677 ( U.S. NIH Grant/Contract )
5P01AG020677-05 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by University of Pittsburgh:
Sleep
Sleep Hygiene
Modest sleep deprivation
Healthy Aging and sleep
Health Promotion