A Study of Yoga for Treating Geriatric Insomnia
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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 |
- 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
- Integrated yoga style practice can improve sleep quality/quantity
- Integrated yoga style practice can improve quality of life.
Objectives:
- 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).
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 |
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| Israel | |
| 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 |
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 |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013