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
  Purpose

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.


Condition Intervention
Primary Geriatric Insomnia
Sleep Initiation and Maintenance Disorders
Other: Integrated Yoga style practice

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • 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



Enrollment: 74
Study Start Date: May 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00661843

Locations
Israel
Shaare Zedek Medical Center, Sleep Lab
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Royal Melbourne Institute of Technology University
The Australia-Israel Scientific Exchange Foundation (AISEF)
Israel Yoga Teachers Association
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Clement Cahan, head of the Sleep Lab, Shaare Zedek Medical Center, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00661843     History of Changes
Other Study ID Numbers: SZMCSL0001
Study First Received: April 16, 2008
Last Updated: October 4, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
insomnia
geriatric
yoga
sleep
electrocardiogram

ClinicalTrials.gov processed this record on October 19, 2014