A Study of Yoga for Treating Geriatric Insomnia

This study has been completed.
Sponsor:
Collaborators:
Royal Melbourne Institute of Technology University
The Australia-Israel Scientific Exchange Foundation (AISEF)
Israel Yoga Teachers Association
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00661843
First received: April 16, 2008
Last updated: October 4, 2010
Last verified: August 2010

April 16, 2008
October 4, 2010
May 2008
January 2009   (final data collection date for primary outcome measure)
  • Subjective sleep and life quality assessment using standard questionnaires and sleep logs [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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

Objective sleep measures using HC1000 sleep analysis system validated using full sleep lab studies in some participants [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00661843 on ClinicalTrials.gov Archive Site
Not Provided
Subjective sleep and life quality assessment using standard questionnaires and sleep logs [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Yoga for Treating Geriatric Insomnia
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Primary Geriatric Insomnia
  • Sleep Initiation and Maintenance Disorders
Other: Integrated Yoga style practice
Intervention constitutes of 2 supervised yoga style classes per week incorporating gentle postures,relaxation and meditation sequences. In addition daily home based sessions of yogic relaxation, and meditation a an audio CD
  • Experimental: 1
    Intervention group: Intervention constitutes of 2 supervised yoga classes per week incorporating gentle Yoga postures, relaxation and meditation sequences In addition: daily home based sessions of yogic relaxation and meditation using a pre-recorded audio CD
    Intervention: Other: Integrated Yoga style practice
  • No Intervention: 2
    Control in waiting to be crossed over after control phase completed. Participants of this group studied using same objective and subjective outcome measures.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
February 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00661843
SZMCSL0001
Yes
Dr. Clement Cahan, head of the Sleep Lab, Shaare Zedek Medical Center, Shaare Zedek Medical Center
Shaare Zedek Medical Center
  • Royal Melbourne Institute of Technology University
  • The Australia-Israel Scientific Exchange Foundation (AISEF)
  • Israel Yoga Teachers Association
Study Chair: Anda Baharav, MD Shaare Zedek Medical Center
Study Chair: Jonathan Halpern, M.Sc. Royal Melbourne Institue of Technology University
Principal Investigator: Clement Cahan, MD Shaare Zedek Medical Center
Shaare Zedek Medical Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP