Aging Well, Sleeping Efficiently: Protecting Health In Later Life

Sleep Clinical Trial

— AgeWise  

Official title:

AGEWISE Project 4: PROTECTING HEALTH IN LATER LIFE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177385
• Other study ID #: IRB #021116
• Secondary ID: 5PO1AG0206775PO1
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 27, 2015
• Start date: June 2003
• Est. completion date: September 2011

Study information

• Verified date: May 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Health Promotion
• Sleep

Intervention

Behavioral:
• Modest sleep deprivation with sleep hygiene education

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnographic measures of sleep consolidation, sleep depth and daytime sleepiness at baseline, 6mos.,12mos., 18mos.,30 mons.
Secondary	Clinical measures of sleep quality, general functioning, mental health at baseline,6 mos., 12 mons., 18mons.,30mons.

External Links

•   AgeWise Program Description