Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2009-03-31
2013-02-28
Brief Summary
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Detailed Description
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We will be conducting a 3-year exploratory pilot randomized-controlled blinded trial (RCT) of this protocol on 56 adults with insomnia disorder, utilizing a control condition involving placement of placebo needles. We seek to determine the effect size of this acupuncture intervention in comparison to the control condition in preparation for a more definitive study, with the future primary aim to determine if acupuncture is effective and well tolerated in the treatment of insomnia. Measures will include self-report and objective measures of sleep quality and duration including polysomnography (PSG). Secondary-exploratory aims will be to determine the impact of this acupuncture protocol on daytime symptoms of insomnia such as fatigue, anxiety, and depression as well as to explore the impact of acupuncture on self-report and objective measures of hyperarousal.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sham acupuncture
Sham acupuncture at non-active acupuncture points, using the Park Sham Device
Acupuncture
Acupuncture, derived from the TCM literature, specific for insomnia
Verum Acupuncture
Acupuncture following a specific TCM-based protocol
Acupuncture
Acupuncture, derived from the TCM literature, specific for insomnia
Interventions
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Acupuncture
Acupuncture, derived from the TCM literature, specific for insomnia
Eligibility Criteria
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Inclusion Criteria
2. Ability to speak, read, and write English;
3. Insomnia disorder, as defined by RDC, of 3 months or greater duration.
Exclusion Criteria
2. Active suicidal ideation or active psychosis, as this may present a concern regarding safety for a subject's participation in this study;
3. Presence of depressive or anxiety disorders of moderate or greater severity based on either HAM-D scores or HAM-A scores of 14 or greater;
4. Presence of unstable medical conditions commonly associated with significant sleep disturbance, e.g. uncompensated congestive heart failure, as this would not be expected to respond to the acupuncture intervention;
5. Presence of other sleep disorder, such as periodic limb movement disorder or sleep apnea, as these conditions would require other medical treatment-this will be based on known history of sleep disorder or findings on screening PSG of apnea-hypopnea index of \> 10 or periodic limb movement index of \>10;
6. Alcohol use \> 14 beverages/week, as this may impact on response to the intervention and assessment measures;
7. Ongoing use of any recreational drugs;
8. Ongoing use of benzodiazepines, prescription hypnotic medication, over-the-counter hypnotic medication, or nutritional supplements with purported hypnotic effects;
9. Ongoing use of other psychotropic medication, such as psychostimulants, or antipsychotics;
10. Caffeine use \> the equivalent of 5 cups of coffee/day;
11. Pregnancy, as the safe use of acupuncture in pregnancy has not been established;
12. Active malignancy, autoimmune condition, or treatment with immunosuppressive drugs;
13. Presence of coagulopathy or use of anticoagulant medication;
14. Active involvement in any psychotherapy or other treatment specifically directed towards insomnia;
15. Prior experience with acupuncture treatment in the last 6 months or prior participation in an acupuncture research study.
18 Years
60 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Ronald M. Glick
Assistant Professor
Principal Investigators
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Ronald M Glick, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Center for Integrative Medicine at UPMC Shadyside
Pittsburgh, Pennsylvania, United States
Countries
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