A Study of Integrated Yoga Practice for Treating Geriatric Insomnia - Full Text View

Sponsors and Collaborators:	Shaare Zedek Medical Center Royal Melbourne Institute of Technology University Australia Israel Scientific Exchange Foundation The Israeli Yoga Teachers Association
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00661843

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.

Hypotheses

Integrated yoga style practice can improve sleep quality/quantity
Integrated yoga style practice can improve quality of life.

Condition	Intervention
Primary Insomnia Sleep Initiation and Maintenance Disorders	Other: Integrated Yoga style practice

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Clinical Trial of Integrated Yoga Style Practice Intervention for Improving Sleep and Quality of Life in the Elderly Population

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

Objective sleep measures using HC1000 sleep analysis system validated using full sleep lab studies in some participants [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective sleep and life quality assessment using standard questionnaires and sleep logs [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intervention group: Intervention constitutes of 2 supervised yoga classes per week. These include gentle postures, breathing, relaxation and meditation sequences in the style of Yoga. In addition: 3-6 home based sessions of relaxation, breathing and meditation per week using a pre-recorded audio CD in the style of Yoga Nidra and guided relaxation protocols.	Other: Integrated Yoga style practice Intervention constitutes of 2 supervised yoga style classes per week. These include gentle postures, breathing, relaxation and meditation sequences in the style of Yoga. In addition: 3 - 6 home based sessions of relaxation, breathing and meditation per week using a an audio CD in the style of Yoga Nidra and relaxation protocols.
2: No Intervention Control in waiting. Participants of this group will studied using same objective and subjective outcome measures but no intervention.

Detailed Description:

Purpose:

Insomnia is common in the elderly population and is associated with increased health problems, reduced quality of life and greater use of sedative hypnotics. This research aims to examine the effectiveness of Integrated Yoga style practice as an intervention for insomnia in elderly people, determine the ability to enhance their quality of life and determine if it is suitable to western culture and conditions.

Hypotheses

Integrated yoga style practice can improve subjective and objective sleep quality/quantity
Integrated yoga style practice can improve subjective quality of life.

Deliverables

Validation of the HC1000 system based on one-lead ECG recording, a tool with sleep staging capabilities that does not require an EEG signal. The only input needed is a whole night electrocardiogram. The output includes:
- Sleep staging - wake, light sleep, Slow Wave Sleep, and REM,
- Body position,
- Respiratory events (Apnea/hypopnea),
- Arousals,
- Basic statistics: total sleep time, wake after Sleep, Sleep and REM Latencies.
Detailed recommendations how to implement Yoga practice for the elderly population for reducing insomnia and increasing well being.
A base for further research of Yoga style intervention for various health disorders in elderly populations.
Expertise in using miniature non-invasive sleep data logging and analysis technology for future sleep and well being research.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 over 2 months
Suffering from any physical or mental health condition or disability 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661843

Locations

Israel
Shaare Zedek Medical Center, Sleep Lab
Jerusalem, Israel, 91031

Sponsors and Collaborators

Shaare Zedek Medical Center

Royal Melbourne Institute of Technology University

Australia Israel Scientific Exchange Foundation

The Israeli Yoga Teachers Association

Investigators

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

Responsible Party:	Shaare Zedek Medical Center ( Dr. Clement Cahan, head of the Sleep Lab, Shaare Zedek Medical Center )
Study ID Numbers:	SZMCSL0001
Study First Received:	April 16, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00661843
Health Authority:	Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:

insomnia
geriatric
yoga
sleep
electrocardiogram

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Quality of Life

Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009