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Clinical Trials/NCT00661843
NCT00661843
Completed
Not Applicable

A Mixed Design, With Wait List Control Crossover to Intervention, Clinical Trial of Integrated Yoga Style Practice Intervention for Improving Sleep and Quality of Life in the Elderly Population

Shaare Zedek Medical Center1 site in 1 country74 target enrollmentMay 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Geriatric Insomnia
Sponsor
Shaare Zedek Medical Center
Enrollment
74
Locations
1
Primary Endpoint
Subjective sleep and life quality assessment using standard questionnaires and sleep logs
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

Insomnia is common in the elderly population and is associated with increased health problems, reduced quality of life and greater use of sleep inducing drugs. This research aims to examine the effectiveness of Yoga practice to treat insomnia in elderly people, determine the ability to enhance their quality of life and determine if it is suitable to western culture and conditions.

Detailed Description

Introduction: Geriatric insomnia is prevalent, reducing life quality, diminishing cognition and increasing risk of accidents and mortality. Treatment with sedative-hypnotic drugs has limited effectiveness and further increases the risk of accidents and falls. Yoga has been shown to increase well-being in the elderly. Hypotheses 1. Integrated yoga style practice can improve sleep quality/quantity 2. Integrated yoga style practice can improve quality of life. Objectives: 1. Examine effectiveness of yoga for insomnia and reduction in use of hypnotics/relaxants in the elderly; 2. Determine whether yoga enhances quality of life in the elderly; and 3. Determine whether yoga is suitable for elderly in western culture(s). Methods: A mixed design crossover controlled trial (n =74, age range 60-87, M = 74.4, SD = 7.1) with 2 weekly classes incorporating physical and meditative yoga, and daily home practice of meditative yoga for 12 weeks. Measures included self-reported assessment of sleep quality (Sleep Logs, KSS, ESS, PSQI, MAPS), mood states (DASS, POMS), general health (SF-36) and mobile objective home sleep studies.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
February 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Age 60 years or older
  • Independent, self mobile
  • Suffering from light to severe primary insomnia

Exclusion Criteria

  • Age less than 60 years
  • Currently or in the past engaged in regular yoga practice
  • Suffering from any physical or mental health condition or disability which may affect sleep, or for which Yoga practice is counter indicated or may lead to health risks or complications.
  • Suffering from co-morbid insomnia in conjunction with another condition clearly salient to sleep disturbance.

Outcomes

Primary Outcomes

Subjective sleep and life quality assessment using standard questionnaires and sleep logs

Time Frame: 24 weeks

all measures taken at baseline and post intervention for all participants participant who crossed over measured pre and post control phase and post intervention phase

Objective home based sleep studies using

Time Frame: 24 weeks

objective sleep studies using embletta mobile sleep recording system in conjunction with the HPC1000 sleep analysis system. all measures taken pre and post intervention. Participants who crossed over measured pre control, post control and post intervention phases

Study Sites (1)

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