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
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
April 18, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedOctober 5, 2010
August 1, 2010
8 months
April 16, 2008
October 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
24 weeks
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
24 weeks
Study Arms (2)
1
EXPERIMENTALIntervention 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
2
NO INTERVENTIONControl in waiting to be crossed over after control phase completed. Participants of this group studied using same objective and subjective outcome measures.
Interventions
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
Eligibility Criteria
You may qualify if:
- Age 60 years or older
- Independent, self mobile
- Suffering from light to severe primary insomnia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shaare Zedek Medical Centerlead
- KTH Royal Institute of Technologycollaborator
- The Australia-Israel Scientific Exchange Foundation (AISEF)collaborator
- Israel Yoga Teachers Associationcollaborator
Study Sites (1)
Shaare Zedek Medical Center, Sleep Lab
Jerusalem, Israel, 91031, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 16, 2008
First Posted
April 18, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
October 5, 2010
Record last verified: 2010-08