A Study of Yoga for Treating Geriatric Insomnia

Study Overview
=================
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 Integrated yoga style practice can improve sleep quality/quantity Integrated yoga style practice can improve quality of life. Objectives: Examine effectiveness of yoga for insomnia and reduction in use of hypnotics/relaxants in the elderly; 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.

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

Conditions
-----------------
Primary Geriatric Insomnia, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Other: Integrated Yoga style practice


Participation Criteria
=================
Eligibility 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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<br>|
| No Intervention: 2<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insomnia, geriatric, yoga, sleep, electrocardiogram