NCT00855140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

3.9 years

First QC Date

March 2, 2009

Last Update Submit

October 5, 2017

Conditions

Primary Insomnia

Keywords

InsomniaPrimary insomniaInsomnia disorderAcupuncture

Outcome Measures

Primary Outcomes (3)

  • Sleep efficiency on polysomnography

    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.

    Baseline and post-intervention

  • Pittsburgh Sleep Quality Index (PSQI)

    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.

    Baseline, EOI, & 3 months post-tx

  • Insomnia Severity Index (ISI)

    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.

    Baseline, EOI, & 3 months post-tx

Secondary Outcomes (7)

  • Epworth Sleepiness Scale (ESS)

    Baseline, EOI, & 3 months post-tx

  • Multidimensional Fatigue Inventory (MFI)

    Baseline, EOI, & 3 months post-tx

  • Inventory for Depressive Symptomatology-Self-Rated (IDS-SR)

    Baseline, EOI, & 3 months post-tx

  • State version of the Spielberger State-Trait Anxiety Inventory (STAI-s)

    Baseline, EOI, & 3 months post-tx

  • The Pre-Sleep Arousal Scale (PSAS)

    Baseline, EOI, & 3 months post-tx

  • +2 more secondary outcomes

Study Arms (2)

Sham acupuncture

PLACEBO COMPARATOR

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

Other: Acupuncture

Verum Acupuncture

EXPERIMENTAL

Acupuncture following a specific TCM-based protocol

Other: Acupuncture

Interventions

AcupunctureOTHER

Acupuncture, derived from the TCM literature, specific for insomnia

Sham acupunctureVerum Acupuncture

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-60;
  • Ability to speak, read, and write English;
  • Insomnia disorder, as defined by RDC, of 3 months or greater duration.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Integrative Medicine at UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Ronald M Glick, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Subjects were unaware of whether they were receiving verum or sham treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 4, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations

US(1)