InsomniaPhase 2NCT00033865
Yoga as a Treatment for Insomnia
A Phase 2 study testing Yoga, Relaxation Exercises, Sleep Hygiene in people with Insomnia, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for insomnia using yoga, relaxation exercises or sleep hygiene. Read more about this study
- Who is it for?
- Ages 25 to 59 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Yoga, Relaxation Exercises, Sleep Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Dec 2008
- Phase
- Phase 2
- 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 25 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A primary complaint of sleep-onset insomnia for at least 6 months.
- Reside in the metropolitan Boston area
Who cannot join
- No current other nonpharmacological treatment for insomnia.
- Ability or willingness to discontinue use of hypnotic medications.
- No rotating or night shift work, or transcontinental travel throughout the course of the study protocol.
- No recent or anticipated major life stressors over the course of the study protocol (e.g. impending divorce or terminal illness of a relative).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital Division of Sleep Medicine
Boston, Massachusetts, 02115
About this study
The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for insomnia using yoga, relaxation exercises or sleep hygiene.
Read the detailed description
Insomnia is a sleep disorder characterized by a chronic difficulty in initiating and maintaining sleep which has a relatively high prevalence and a significant socioeconomic cost. There is good evidence that cognitive and/or physiological arousal, associated with sustained sympathetic activation, is one of the underlying causes of insomnia. Relaxation treatments such as progressive relaxation and meditation which address the cognitive and somatic arousal associated with insomnia have been found to be effective. Yoga is a comprehensive discipline which includes physical exercises, postures, breathing techniques, and meditation, for the purpose of improving health and well being. Research studies have documented the effectiveness of yoga in reducing sympathetic activation and cognitive and somatic arousal and in the treatment of specific medical disorders. Although it has been used and recommended for the treatment of insomnia, its effectiveness has not been evaluated in a randomized, controlled study. The aim of this proposal is to evaluate the effectiveness of yoga, relaxation exercises or sleep hygiene in the treatment of chronic psychophysiological insomnia. A subjective measure of sleep onset latency will be derived from daily sleep diaries, and an objective measure will be drawn from polysomnographic recordings. Sleep onset latency will be evaluated before and after a two month treatment period in a total of 48 young men and women who have been carefully screened for psychiatric and medical disorders. Subjects will be assigned to a yoga, relaxation exercise, or sleep hygiene treatment group. We anticipate that yoga practice will prove to be an effective treatment for insomnia which will yield significant improvements in sleep onset latency. We also anticipate that these improvements will be maintained at long-term follow up evaluation.
- Conditions
- Insomnia
- Being tested
- Yoga, Relaxation Exercises, Sleep Hygiene
- Keywords
- Insomnia, Yoga, Meditation, Behavioral treatment
- 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.
Yoga, Relaxation Exercises, Sleep HygieneBehavioural
Sleep hygiene and relaxation exercises, with additional yoga
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Yoga treatment for 8 weeks Receives: Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene |
| 2 | No intervention | Sleep hygiene instructions only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset latency
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2002 (estimated)
- Study startApr 2001
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Sat Bir Singh Khalsa, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033865
- Sponsor's protocol ID
- R21 AT000066-01A1
- Status last verified
- Apr 2015
- First submitted
- 11 Apr 2002
- Last updated
- 28 Apr 2015
- Results posted
- No
Publications
Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79.
PubMed 7896994Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
PubMed 8037252Choliz M. A breathing-retraining procedure in treatment of sleep-onset insomnia: theoretical basis and experimental findings. Percept Mot Skills. 1995 Apr;80(2):507-13. doi: 10.2466/pms.1995.80.2.507.
PubMed 7675582Integration of behavioral and relaxation approaches into the treatment of chronic pain and insomnia. NIH Technology Assessment Panel on Integration of Behavioral and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia. JAMA. 1996 Jul 24-31;276(4):313-8. doi: 10.1001/jama.1996.03540040057033.
PubMed 8656544Woolfolk RL, Carr-Kaffashan L, McNulty TF. Meditation training as a treatment for insomnia. Behav Ther 1976;7:359-65.
Carr-Kaffashan L, Woolfolk RL. Active and placebo effects in treatment of moderate and severe insomnia. J Consult Clin Psychol. 1979 Dec;47(6):1072-80. doi: 10.1037//0022-006x.47.6.1072. No abstract available.
PubMed 41856Schoicket SL, Bertelson AD, Lacks P. Is sleep hygiene a sufficient treatment for sleep-maintenance insomnia? Behav Ther 1988;19:183-90.
Jacobs GD, Rosenberg PA, Friedman R, Matheson J, Peavy GM, Domar AD, Benson H. Multifactor behavioral treatment of chronic sleep-onset insomnia using stimulus control and the relaxation response. A preliminary study. Behav Modif. 1993 Oct;17(4):498-509. doi: 10.1177/01454455930174005.
PubMed 8216184Koch, U., Volk, S., Heidenreich, T., and Pflug, B. Yoga treatment in psychophysiological insomnia. Journal of Sleep Research 7(Suppl. 2), 137. 1998.
Joshi, KS. Yogic treatment of insomnia: An experimental study. Yoga Mimamsa 1992;30:24-26.
Khalsa SBS, Goldstein MR. Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison. J Clin Sleep Med. 2021 Sep 1;17(9):1841-1852. doi: 10.5664/jcsm.9320.
PubMed 33928908
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga as a Treatment for Insomnia
- ClinicalTrials.gov ID
- NCT00033865
- Acronym / sponsor ID
- R21 AT000066-01A1
- Conditions
- Insomnia
- Keywords
- Insomnia, Yoga, Meditation, Behavioral treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Apr 2001
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Apr 2002 (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.
The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for insomnia using yoga, relaxation exercises or sleep hygiene.
Detailed description
Insomnia is a sleep disorder characterized by a chronic difficulty in initiating and maintaining sleep which has a relatively high prevalence and a significant socioeconomic cost. There is good evidence that cognitive and/or physiological arousal, associated with sustained sympathetic activation, is one of the underlying causes of insomnia. Relaxation treatments such as progressive relaxation and meditation which address the cognitive and somatic arousal associated with insomnia have been found to be effective. Yoga is a comprehensive discipline which includes physical exercises, postures, breathing techniques, and meditation, for the purpose of improving health and well being. Research studies have documented the effectiveness of yoga in reducing sympathetic activation and cognitive and somatic arousal and in the treatment of specific medical disorders. Although it has been used and recommended for the treatment of insomnia, its effectiveness has not been evaluated in a randomized, controlled study. The aim of this proposal is to evaluate the effectiveness of yoga, relaxation exercises or sleep hygiene in the treatment of chronic psychophysiological insomnia. A subjective measure of sleep onset latency will be derived from daily sleep diaries, and an objective measure will be drawn from polysomnographic recordings. Sleep onset latency will be evaluated before and after a two month treatment period in a total of 48 young men and women who have been carefully screened for psychiatric and medical disorders. Subjects will be assigned to a yoga, relaxation exercise, or sleep hygiene treatment group. We anticipate that yoga practice will prove to be an effective treatment for insomnia which will yield significant improvements in sleep onset latency. We also anticipate that these improvements will be maintained at long-term follow up evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Yoga, Relaxation Exercises, Sleep HygieneYoga treatment for 8 weeks |
| 2 | No intervention | –Sleep hygiene instructions only |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A primary complaint of sleep-onset insomnia for at least 6 months.
Key exclusion criteria (4 listed)
- No current other nonpharmacological treatment for insomnia.
- Ability or willingness to discontinue use of hypnotic medications.
- No rotating or night shift work, or transcontinental travel throughout the course of the study protocol.
- No recent or anticipated major life stressors over the course of the study protocol (e.g. impending divorce or terminal illness of a relative).
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 |
|---|---|---|
| Yoga, Relaxation Exercises, Sleep HygieneSleep hygiene and relaxation exercises, with additional yoga | Behavioural | 1 |
Primary outcome
Sleep onset latency
Time frame: 8 weeks
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 28 Apr 2015.
- Background: PubMed 7896994Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79.
- Background: PubMed 8037252Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
- Background: PubMed 7675582Choliz M. A breathing-retraining procedure in treatment of sleep-onset insomnia: theoretical basis and experimental findings. Percept Mot Skills. 1995 Apr;80(2):507-13. doi: 10.2466/pms.1995.80.2.507.
- Background: PubMed 8656544Integration of behavioral and relaxation approaches into the treatment of chronic pain and insomnia. NIH Technology Assessment Panel on Integration of Behavioral and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia. JAMA. 1996 Jul 24-31;276(4):313-8. doi: 10.1001/jama.1996.03540040057033.
- BackgroundWoolfolk RL, Carr-Kaffashan L, McNulty TF. Meditation training as a treatment for insomnia. Behav Ther 1976;7:359-65.
- Background: PubMed 41856Carr-Kaffashan L, Woolfolk RL. Active and placebo effects in treatment of moderate and severe insomnia. J Consult Clin Psychol. 1979 Dec;47(6):1072-80. doi: 10.1037//0022-006x.47.6.1072. No abstract available.
- BackgroundSchoicket SL, Bertelson AD, Lacks P. Is sleep hygiene a sufficient treatment for sleep-maintenance insomnia? Behav Ther 1988;19:183-90.
- Background: PubMed 8216184Jacobs GD, Rosenberg PA, Friedman R, Matheson J, Peavy GM, Domar AD, Benson H. Multifactor behavioral treatment of chronic sleep-onset insomnia using stimulus control and the relaxation response. A preliminary study. Behav Modif. 1993 Oct;17(4):498-509. doi: 10.1177/01454455930174005.
- BackgroundKoch, U., Volk, S., Heidenreich, T., and Pflug, B. Yoga treatment in psychophysiological insomnia. Journal of Sleep Research 7(Suppl. 2), 137. 1998.
- BackgroundJoshi, KS. Yogic treatment of insomnia: An experimental study. Yoga Mimamsa 1992;30:24-26.
- Derived from this study: PubMed 33928908Khalsa SBS, Goldstein MR. Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison. J Clin Sleep Med. 2021 Sep 1;17(9):1841-1852. doi: 10.5664/jcsm.9320.
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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.
Sat Bir Singh Khalsa, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yoga, Relaxation Exercises, Sleep Hygiene in people with Insomnia, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 2 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 28 Apr 2015. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sleep onset latency (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00033865, which also lists 11 linked publications.
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 28 Apr 2015; AzTrials last refreshed its copy on 4 Nov 2026.