A Study of Yoga for Treating Geriatric Insomnia
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|ClinicalTrials.gov Identifier: NCT00661843|
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : October 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Primary Geriatric Insomnia Sleep Initiation and Maintenance Disorders||Other: Integrated Yoga style practice||Not Applicable|
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.
- Integrated yoga style practice can improve sleep quality/quantity
- Integrated yoga style practice can improve quality of life.
- Examine effectiveness of yoga for insomnia and reduction in use of hypnotics/relaxants in the elderly;
- Determine whether yoga enhances quality of life in the elderly; and 3. Determine whether yoga is suitable for elderly in western culture(s).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||February 2009|
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.
- 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
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): NCT00661843
|Shaare Zedek Medical Center, Sleep Lab|
|Jerusalem, Israel, 91031|
|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|