Primary InsomniaNCT00855140

Acupuncture for the Treatment of Insomnia

A study testing Acupuncture in people with Primary Insomnia, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Primary Insomnia
What is being tested?: Acupuncture
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Feb 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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;

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Integrative Medicine at UPMC Shadyside
Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Acupuncture for the Treatment of Insomnia - A Pilot Study

Read the 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
Being tested: Acupuncture
Keywords: Insomnia, Primary insomnia, Insomnia disorder, Acupuncture
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureOther
Acupuncture, derived from the TCM literature, specific for insomnia

Study groups in NCT00855140
Study group	Role	What they receive
Sham acupuncture	Placebo comparator	Sham acupuncture at non-active acupuncture points, using the Park Sham Device Receives: Other: Acupuncture
Verum Acupuncture	Experimental	Acupuncture following a specific TCM-based protocol Receives: Other: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline, EOI, & 3 months post-tx

Secondary outcomes (7)

Epworth Sleepiness Scale (ESS)
evaluates the tendency to fall asleep during various daytime activities
Measured: Baseline, EOI, & 3 months post-tx
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.
Measured: Baseline, EOI, & 3 months post-tx
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
Measured: Baseline, EOI, & 3 months post-tx
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
Measured: Baseline, EOI, & 3 months post-tx
The Pre-Sleep Arousal Scale (PSAS)
16-item self-report questionnaire with two 8-question subscales representing the cognitive and somatic components of arousal
Measured: Baseline, EOI, & 3 months post-tx
Pittsburgh Sleep Diary (PghSD) and actigraphy recording
A daily record of sleep quality and sleep-related behaviors that includes bedtime and waketime portions.
Measured: Baseline, EOI, & 3 months post-tx
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.
Measured: Baseline & EOI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Feb 2013

First posted4 Mar 2009 (estimated)
Study startMar 2009
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary InsomniaStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00855140
Sponsor's protocol ID: 1R21AT004429-01A1
Other IDs: R21AT004429
Status last verified: Oct 2017
First submitted: 2 Mar 2009
Last updated: 9 Oct 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupuncture for the Treatment of Insomnia - A Pilot Study
ClinicalTrials.gov ID: NCT00855140
Acronym / sponsor ID: 1R21AT004429-01A1
Conditions: Primary Insomnia
Keywords: Insomnia, Primary insomnia, Insomnia disorder, Acupuncture
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Mar 2009
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 4 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham acupuncture	Placebo comparator	Other: AcupunctureSham acupuncture at non-active acupuncture points, using the Park Sham Device
Verum Acupuncture	Experimental	Other: AcupunctureAcupuncture following a specific TCM-based protocol

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcupunctureAcupuncture, derived from the TCM literature, specific for insomnia	Other	Sham acupuncture, Verum Acupuncture

Primary outcome

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.

7 secondary outcomes

Epworth Sleepiness Scale (ESS)
Time frame: Baseline, EOI, & 3 months post-tx
Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, EOI, & 3 months post-tx
Inventory for Depressive Symptomatology-Self-Rated (IDS-SR)
Time frame: Baseline, EOI, & 3 months post-tx
State version of the Spielberger State-Trait Anxiety Inventory (STAI-s)
Time frame: Baseline, EOI, & 3 months post-tx
The Pre-Sleep Arousal Scale (PSAS)
Time frame: Baseline, EOI, & 3 months post-tx
Pittsburgh Sleep Diary (PghSD) and actigraphy recording
Time frame: Baseline, EOI, & 3 months post-tx
Autonomic arousal as measured by HRV & Q-EEG during sleep recording
Time frame: Baseline & EOI

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ronald M Glick, MD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Primary Insomnia, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep efficiency on polysomnography (time frame: Baseline and post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00855140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.