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Primary Insomnia | Acupuncture for the Treatment of Insomnia

Primary Insomnia research study

What is the primary objective of this study?

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 individuals with insomnia and can decrease hyperarousal. This blinded RCT will investigate the impact of a standardized acupuncture protocol on insomnia, daytime symptoms, and hyperarousal.

Who is eligible to participate?

Inclusion Criteria: 1. Ages 18-60; 2. Ability to speak, read, and write English; 3. Insomnia disorder, as defined by RDC, of 3 months or greater duration. Exclusion Criteria: 1. 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; 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Primary Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:AcupunctureAcupuncture, derived from the TCM literature, specific for insomnia

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sham acupunctureSham acupuncture at non-active acupuncture points, using the Park Sham Device

Verum AcupunctureAcupuncture following a specific TCM-based protocol

Study Status

Completed

Start Date: March 2009

Completed Date: February 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Sleep efficiency on polysomnography

Secondary Outcome: Epworth Sleepiness Scale (ESS)

Study sponsors, principal investigator, and references

Principal Investigator: Ronald M Glick, MD

Lead Sponsor: University of Pittsburgh

Collaborator: National Center for Complementary and Integrative Health (NCCIH)

More information:https://clinicaltrials.gov/show/NCT00855140

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