Clinical trial NCT00855140: Acupuncture for the Treatment of Insomnia
Official title: Acupuncture for the Treatment of Insomnia - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Insomnia
Keywords: Insomnia
Primary insomnia
Insomnia disorder
Acupuncture
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-03-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep efficiency on polysomnography
timeFrame: Baseline and post-intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, EOI, & 3 months post-tx
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, EOI, & 3 months post-tx
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, EOI, & 3 months post-tx
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, EOI, & 3 months post-tx
measure: Inventory for Depressive Symptomatology-Self-Rated (IDS-SR)
timeFrame: Baseline, EOI, & 3 months post-tx
measure: State version of the Spielberger State-Trait Anxiety Inventory (STAI-s)
timeFrame: Baseline, EOI, & 3 months post-tx
measure: The Pre-Sleep Arousal Scale (PSAS)
timeFrame: Baseline, EOI, & 3 months post-tx
measure: Pittsburgh Sleep Diary (PghSD) and actigraphy recording
timeFrame: Baseline, EOI, & 3 months post-tx
measure: Autonomic arousal as measured by HRV & Q-EEG during sleep recording
timeFrame: Baseline & EOI
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Center for Integrative Medicine at UPMC Shadyside
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ronald M Glick, MD
role: PRINCIPAL_INVESTIGATOR
References: