A Study of Yoga for Treating Geriatric Insomnia
Primary Purpose
Primary Geriatric Insomnia, Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Integrated Yoga style practice
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Geriatric Insomnia focused on measuring insomnia, geriatric, yoga, sleep, electrocardiogram
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.
Sites / Locations
- Shaare Zedek Medical Center, Sleep Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
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
Control in waiting to be crossed over after control phase completed. Participants of this group studied using same objective and subjective outcome measures.
Outcomes
Primary Outcome Measures
Subjective sleep and life quality assessment using standard questionnaires and sleep logs
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00661843
First Posted
April 16, 2008
Last Updated
October 4, 2010
Sponsor
Shaare Zedek Medical Center
Collaborators
KTH Royal Institute of Technology, The Australia-Israel Scientific Exchange Foundation (AISEF), Israel Yoga Teachers Association
1. Study Identification
Unique Protocol Identification Number
NCT00661843
Brief Title
A Study of Yoga for Treating Geriatric Insomnia
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 Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
Collaborators
KTH Royal Institute of Technology, The Australia-Israel Scientific Exchange Foundation (AISEF), Israel Yoga Teachers Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Geriatric Insomnia, Sleep Initiation and Maintenance Disorders
Keywords
insomnia, geriatric, yoga, sleep, electrocardiogram
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
No Intervention
Arm Description
Control in waiting to be crossed over after control phase completed. Participants of this group studied using same objective and subjective outcome measures.
Intervention Type
Other
Intervention Name(s)
Integrated Yoga style practice
Intervention Description
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
Primary Outcome Measure Information:
Title
Subjective sleep and life quality assessment using standard questionnaires and sleep logs
Description
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
Time Frame
24 weeks
Title
Objective home based sleep studies using
Description
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
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anda Baharav, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jonathan Halpern, M.Sc.
Organizational Affiliation
Royal Melbourne Institue of Technology University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Clement Cahan, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center, Sleep Lab
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
12. IPD Sharing Statement
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A Study of Yoga for Treating Geriatric Insomnia
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