NCT00855140

Acupuncture for the Treatment of Insomnia

Acupuncture for the Treatment of Insomnia - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 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.

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 high medical and societal costs. Benzodiazepine receptor agonists (BzRA's) and cognitive behavioral therapies are common treatments, but despite these, insomnia remains a pervasive problem. Complementary and alternative medicine (CAM) treatments are being used widely for the treatment of insomnia, but many of these modalities have sparse research support. There are numerous reports in the Traditional Chinese Medicine (TCM)literature of dramatic benefits of acupuncture for the treatment of insomnia, but carefully designed studies are limited. Insomnia has been associated with hyperarousal and acupuncture has documented effects on autonomics with a shift towards parasympathetic predominance. In consultation with experts in acupuncture and TCM, we developed a protocol for the treatment of insomnia and have used it clinically with good success. 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

• Primary Insomnia

Interventions

Type	Name	Description
OTHER	Acupuncture	Acupuncture, derived from the TCM literature, specific for insomnia

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-03-04
• Last updated: 2017-10-09

Locations

1 site across 1 country: United States