A Study of Yoga for Treating Geriatric Insomnia

Sleep Initiation and Maintenance Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661843
• Other study ID #: SZMCSL0001
• Status: Completed
• Phase: N/A
• First received: April 16, 2008
• Last updated: October 4, 2010
• Start date: May 2008
• Est. completion date: February 2009

Study information

• Verified date: August 2010
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Primary Geriatric Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center, Sleep Lab	Jerusalem

Sponsors (4)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center	Israel Yoga Teachers Association, Royal Melbourne Institute of Technology University, The Australia-Israel Scientific Exchange Foundation (AISEF)

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No