Clinical trial NCT00661843: A Study of Yoga for Treating Geriatric Insomnia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Geriatric Insomnia
Sleep Initiation and Maintenance Disorders
Keywords: insomnia
geriatric
yoga
sleep
electrocardiogram
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
Collaborators: name: KTH Royal Institute of Technology
name: The Australia-Israel Scientific Exchange Foundation (AISEF)
name: Israel Yoga Teachers Association
First posted: 2008-04-18
Enrollment: 74
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Subjective sleep and life quality assessment using standard questionnaires and sleep logs
timeFrame: 24 weeks
measure: Objective home based sleep studies using
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center, Sleep Lab
Study officials:
affiliation: Shaare Zedek Medical Center
name: Anda Baharav, MD
role: STUDY_CHAIR
affiliation: Royal Melbourne Institue of Technology University
name: Jonathan Halpern, M.Sc.
role: STUDY_CHAIR
affiliation: Shaare Zedek Medical Center
name: Clement Cahan, MD
role: PRINCIPAL_INVESTIGATOR
References: