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View Clinical Trial (Medical Research Study)
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Insomnia: Behavioral Treatments - NCT00280020-90095 (Clinical Trial 136180)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy136180.aspx
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| City: |
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Los Angeles |
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State:
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CA |
| Zip Code: |
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90095 |
| Conditions: |
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Aging - Insomnia |
| Purpose: |
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The purpose of this study is to evaluate whether Tai Chi Chih vs. cognitive behavioral
therapy vs. sleep education reduces insomnia in older adults. The secondary goal of the
study is to determine whether the behavioral treatment of insomnia alters proinflammatory
cytokine activity.
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| Study summary: |
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Insomnia is a prominent complaint in late-life. However, little scientific effort has been
directed toward identifying the biological mechanisms that are related to abnormal sleep or
to evaluating the efficacy of behavioral treatments for insomnia in older adults. Basic
observations demonstrate that proinflammatory cytokines play a key role in the regulation of
sleep. Previous research shows that cytokines are reciprocally linked with abnormal sleep.
This trial builds upon these findings and extends a program of study that has examined the
efficacy of behavioral interventions on health outcomes in the elderly.
Preliminary studies found that Tai Chi Chih (TCC), a slow moving meditation, contributes to
improvements in subjective sleep quality, sleep amounts and sleep efficiency, alterations in
sympathetic activity, decreases in proinflammatory cytokines, and improvements in health
functioning in community-dwelling older adults. Additionally, cognitive behavior therapy
(CBT) confers benefits on sleep outcomes.
In this randomized, controlled trial, 150 older adults will be randomly assigned to CBT,
TCC, or sleep hygiene/education control (EC) over 16 weeks and followed for one year. The
aims of this project are to: 1) evaluate the effects of CBT vs TCC vs. EC on objective and
subjective measures of sleep and on fatigue, mood, and health functioning in older adults
with insomnia; 2) determine the effects of CBT vs.TCC vs. EC on measures of proinflammatory
cytokine activity and sympathovagal balance, and whether these two biological mechanisms are
related to changes of disordered sleep over the course of the treatment trial; and 3)
evaluate whether circulating levels of proinflammatory cytokines are associated with
measures of sleep continuity in older adults with insomnia over the treatment trial. This
study will advance psychobiological models of disordered sleep and the potential benefits of
two readily exportable behavioral interventions for promoting improvements in sleep outcomes
in the elderly. |
| Criteria: |
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Inclusion Criteria:
- Older than 55 years of age at time of entry
- Sleep-onset delay, maintenance insomnia, or terminal insomnia
- Difficulties with sleep for a minimum of 3 nights per week
- Insomnia duration of at least 6 months
- Complaint of at least 1 negative effect during waking hours (e.g., fatigue, impaired
functioning, mood disturbances) attributed to insomnia
- Habitual sleep-wake schedule reporting "lights-out" between 9:00 PM and midnight
- Accessible geographically
Exclusion Criteria:
- Evidence that insomnia is directly related to a medical disorder (e.g.,
hyperthyroidism) or effects of a medication that affects sleep structure and/or
immune functioning
- Presence of sleep apnea or periodic limb movements during sleep
- Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome)
- Regular use of a hypnotic or psychotropic medication (sleeping pills) and/or current
psychotherapy or other behavioral therapy that would confound CBT or TCC
- Current history of a major psychiatric disorder (e.g. current major depression,
alcohol or substance dependence, anxiety disorder)
- Cognitive impairment as suggested by a score lower than 23 on the Mini-Mental State
examination
- Abnormal screening laboratory tests (e.g., abnormal thyroid hormone, elevated TSH,
positive screening for HIV or hepatitis C)
- Smokers will also be excluded because of potential confounding effects on markers of
inflammation
- Body mass index that is greater than 30 kg/m2 as obesity is associated with excessive
levels of inflammatory markers
- Women must be post-menopausal
- Unable to commit to intervention schedule |
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| Study is available at: |
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Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, CA 90095
United States
Primary Contact:
Michael Irwin, MD
Email: mirwin1@ucla.edu
Phone: 310-825-8281
Secondary Contact:
Michael R. Irwin, MD
Email: mirwin1@ucla.edu
Phone: 310-825-8281 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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