Acupuncture for the Treatment of Insomnia
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|ClinicalTrials.gov Identifier: NCT00855140|
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Insomnia||Other: Acupuncture||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Subjects were unaware of whether they were receiving verum or sham treatment.|
|Official Title:||Acupuncture for the Treatment of Insomnia - A Pilot Study|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Placebo Comparator: Sham acupuncture
Sham acupuncture at non-active acupuncture points, using the Park Sham Device
Acupuncture, derived from the TCM literature, specific for insomnia
Experimental: Verum Acupuncture
Acupuncture following a specific TCM-based protocol
Acupuncture, derived from the TCM literature, specific for insomnia
- Sleep efficiency on polysomnography [ Time Frame: Baseline and post-intervention ]PSG is the "gold standard" objective measure of sleep, which complements in-home diary measures and actigraphy. PSG provides objective physiologic data under controlled, albeit artificial (laboratory) conditions and is considered an essential component of demonstrating the efficacy of both drug and non-pharmacologic treatments of insomnia.
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, EOI, & 3 months post-tx ]A 19-item questionnaire developed by Buysse et. al. that rates the subject's habitual sleep over the past month(109). The 19 questions are combined into seven clinically-derived component scores, each weighted equally from 0-3. The seven component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
- Insomnia Severity Index (ISI) [ Time Frame: Baseline, EOI, & 3 months post-tx ]A 7-item survey which rates satisfaction with different aspects of sleep over the prior two weeks on a 0-4 Likert scale for a total score of 28, with a higher score reflecting greater severity of insomnia(126). Criteria are specified to categorize response into one of four severity groups, with a change of one level considered significant.
- Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline, EOI, & 3 months post-tx ]evaluates the tendency to fall asleep during various daytime activities
- Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline, EOI, & 3 months post-tx ]20-item self-report instrument designed to measure fatigue. It includes 5 subscales addressing dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity.
- Inventory for Depressive Symptomatology-Self-Rated (IDS-SR) [ Time Frame: Baseline, EOI, & 3 months post-tx ]28-item self-rating scale for depressive symptoms with each item rated on a 0-3 Likert scale with higher scores representing increasing depressive symptoms
- State version of the Spielberger State-Trait Anxiety Inventory (STAI-s) [ Time Frame: Baseline, EOI, & 3 months post-tx ]validated measure of state anxiety in which subjects are asked to rate the severity of mood and anxiety symptoms at this moment, with 20 symptoms rated on a 1-4 Likert scale
- The Pre-Sleep Arousal Scale (PSAS) [ Time Frame: Baseline, EOI, & 3 months post-tx ]16-item self-report questionnaire with two 8-question subscales representing the cognitive and somatic components of arousal
- Pittsburgh Sleep Diary (PghSD) and actigraphy recording [ Time Frame: Baseline, EOI, & 3 months post-tx ]A daily record of sleep quality and sleep-related behaviors that includes bedtime and waketime portions.
- Autonomic arousal as measured by HRV & Q-EEG during sleep recording [ Time Frame: Baseline & EOI ]A standardized battery of mild psychological stressors that have been used successfully here at the University of Pittsburgh in studies of autonomic reactivity and which we are currently using to study the effects of CAM interventions on autonomic reactivity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855140
|United States, Pennsylvania|
|Center for Integrative Medicine at UPMC Shadyside|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ronald M Glick, MD||University of Pittsburgh|