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Acupuncture for the Treatment of Insomnia

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring Insomnia, Primary insomnia, Insomnia disorder, Acupuncture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Integrative Medicine at UPMC Shadyside

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sham acupuncture

Verum Acupuncture

Arm Description

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

Acupuncture following a specific TCM-based protocol

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Epworth Sleepiness Scale (ESS)
evaluates the tendency to fall asleep during various daytime activities
Multidimensional Fatigue Inventory (MFI)
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)
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)
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)
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
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
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.

Full Information

First Posted
March 2, 2009
Last Updated
October 5, 2017
Sponsor
University of Pittsburgh
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00855140
Brief Title
Acupuncture for the Treatment of Insomnia
Official Title
Acupuncture for the Treatment of Insomnia - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Insomnia, Primary insomnia, Insomnia disorder, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Subjects were unaware of whether they were receiving verum or sham treatment.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham acupuncture
Arm Type
Placebo Comparator
Arm Description
Sham acupuncture at non-active acupuncture points, using the Park Sham Device
Arm Title
Verum Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture following a specific TCM-based protocol
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture, derived from the TCM literature, specific for insomnia
Primary Outcome Measure Information:
Title
Sleep efficiency on polysomnography
Description
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.
Time Frame
Baseline and post-intervention
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Baseline, EOI, & 3 months post-tx
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
Baseline, EOI, & 3 months post-tx
Secondary Outcome Measure Information:
Title
Epworth Sleepiness Scale (ESS)
Description
evaluates the tendency to fall asleep during various daytime activities
Time Frame
Baseline, EOI, & 3 months post-tx
Title
Multidimensional Fatigue Inventory (MFI)
Description
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.
Time Frame
Baseline, EOI, & 3 months post-tx
Title
Inventory for Depressive Symptomatology-Self-Rated (IDS-SR)
Description
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
Time Frame
Baseline, EOI, & 3 months post-tx
Title
State version of the Spielberger State-Trait Anxiety Inventory (STAI-s)
Description
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
Time Frame
Baseline, EOI, & 3 months post-tx
Title
The Pre-Sleep Arousal Scale (PSAS)
Description
16-item self-report questionnaire with two 8-question subscales representing the cognitive and somatic components of arousal
Time Frame
Baseline, EOI, & 3 months post-tx
Title
Pittsburgh Sleep Diary (PghSD) and actigraphy recording
Description
A daily record of sleep quality and sleep-related behaviors that includes bedtime and waketime portions.
Time Frame
Baseline, EOI, & 3 months post-tx
Title
Autonomic arousal as measured by HRV & Q-EEG during sleep recording
Description
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.
Time Frame
Baseline & EOI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18-60; Ability to speak, read, and write English; Insomnia disorder, as defined by RDC, of 3 months or greater duration. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Glick, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Integrative Medicine at UPMC Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

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Acupuncture for the Treatment of Insomnia

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