Status:
COMPLETED
Acupuncture for the Treatment of Insomnia
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Primary Insomnia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Insomnia is a common and disabling condition associated with psychiatric and medical comorbidities and often persists despite currently available treatments. Acupuncture has been reported to benefit i...
Detailed Description
Insomnia is a common problem that is disabling and that frequently persists despite available medical and behavioral approaches. It is associated significant psychiatric and medical comorbidities and ...
Eligibility Criteria
Inclusion
- Ages 18-60;
- Ability to speak, read, and write English;
- Insomnia disorder, as defined by RDC, of 3 months or greater duration.
Exclusion
- Presence of serious psychiatric Axis I DSM-IV disorders such as bipolar or psychotic disorders-as individuals with conditions may respond differently than insomnia disorder to the acupuncture intervention, potentially confounding the results;
- Active suicidal ideation or active psychosis, as this may present a concern regarding safety for a subject's participation in this study;
- 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;
- 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;
- 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;
- Alcohol use \> 14 beverages/week, as this may impact on response to the intervention and assessment measures;
- Ongoing use of any recreational drugs;
- Ongoing use of benzodiazepines, prescription hypnotic medication, over-the-counter hypnotic medication, or nutritional supplements with purported hypnotic effects;
- Ongoing use of other psychotropic medication, such as psychostimulants, or antipsychotics;
- Caffeine use \> the equivalent of 5 cups of coffee/day;
- Pregnancy, as the safe use of acupuncture in pregnancy has not been established;
- Active malignancy, autoimmune condition, or treatment with immunosuppressive drugs;
- Presence of coagulopathy or use of anticoagulant medication;
- Active involvement in any psychotherapy or other treatment specifically directed towards insomnia;
- Prior experience with acupuncture treatment in the last 6 months or prior participation in an acupuncture research study.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00855140
Start Date
March 1 2009
End Date
February 1 2013
Last Update
October 9 2017
Active Locations (1)
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1
Center for Integrative Medicine at UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232