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Trial record 8 of 446 for:    shaare zedek

A Study of Yoga for Treating Geriatric Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661843
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : October 5, 2010
Sponsor:
Collaborators:
KTH Royal Institute of Technology
The Australia-Israel Scientific Exchange Foundation (AISEF)
Israel Yoga Teachers Association
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE April 16, 2008
First Posted Date  ICMJE April 18, 2008
Last Update Posted Date October 5, 2010
Study Start Date  ICMJE May 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2010)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2008)
Objective sleep measures using HC1000 sleep analysis system validated using full sleep lab studies in some participants [ Time Frame: 20 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2008)
Subjective sleep and life quality assessment using standard questionnaires and sleep logs [ Time Frame: 20 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Yoga for Treating Geriatric Insomnia
Official Title  ICMJE 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
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

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Primary Geriatric Insomnia
  • Sleep Initiation and Maintenance Disorders
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Other: Integrated Yoga style practice
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2010)
74
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2008)
50
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661843
Other Study ID Numbers  ICMJE SZMCSL0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Clement Cahan, head of the Sleep Lab, Shaare Zedek Medical Center, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE
  • KTH Royal Institute of Technology
  • The Australia-Israel Scientific Exchange Foundation (AISEF)
  • Israel Yoga Teachers Association
Investigators  ICMJE
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
PRS Account Shaare Zedek Medical Center
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP