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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders; Primary Geriatric Insomnia
• Intervention / Treatment: Other: Integrated Yoga style practice

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: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Collaborators: KTH Royal Institute of Technology; The Australia-Israel Scientific Exchange Foundation (AISEF); Israel 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

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: April 16, 2008
• First Submitted That Met QC Criteria: April 16, 2008
• First Posted (ESTIMATE): April 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2010
• Last Update Submitted That Met QC Criteria: October 4, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: sleep; insomnia; yoga; geriatric; electrocardiogram
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: SZMCSL0001