Primary Geriatric InsomniaNCT00661843
A Study of Yoga for Treating Geriatric Insomnia
A study testing Integrated Yoga style practice in people with Primary Geriatric Insomnia and Sleep Initiation and Maintenance Disorders, run by Shaare Zedek Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Primary Geriatric Insomnia, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Integrated Yoga style practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older
- Independent, self mobile
- Suffering from light to severe primary insomnia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Integrated Yoga style practice
- Keywords
- insomnia, geriatric, yoga, sleep, electrocardiogram
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Yoga style practiceOther
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Other: Integrated Yoga style practice |
| 2 | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Geriatric InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KTH Royal Institute of Technology, The Australia-Israel Scientific Exchange Foundation (AISEF), Israel Yoga Teachers Association
- Investigators
- Anda Baharav, MD, Study chair, Shaare Zedek Medical CenterJonathan Halpern, M.Sc., Study chair, Royal Melbourne Institue of Technology UniversityClement Cahan, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661843
- Sponsor's protocol ID
- SZMCSL0001
- Status last verified
- Aug 2010
- First submitted
- 16 Apr 2008
- Last updated
- 5 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00661843
- Acronym / sponsor ID
- SZMCSL0001
- Keywords
- insomnia, geriatric, yoga, sleep, electrocardiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- KTH Royal Institute of Technology, The Australia-Israel Scientific Exchange Foundation (AISEF), Israel Yoga Teachers Association
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Integrated Yoga style practiceIntervention 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 |
| 2 | No intervention | –Control in waiting to be crossed over after control phase completed. Participants of this group studied using same objective and subjective outcome measures. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60 years or older
- Independent, self mobile
- Suffering from light to severe primary insomnia
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Yoga style practiceIntervention 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 | Other | 1 |
Primary outcome
Subjective sleep and life quality assessment using standard questionnaires and sleep logs
Time frame: 24 weeks
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
Objective home based sleep studies using
Time frame: 24 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anda Baharav, MD study chair
Shaare Zedek Medical Center
Jonathan Halpern, M.Sc. study chair
Royal Melbourne Institue of Technology University
Clement Cahan, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Yoga style practice in people with Primary Geriatric Insomnia and Sleep Initiation and Maintenance Disorders, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective sleep and life quality assessment using standard questionnaires and sleep logs (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2010.