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Behavioural Intervention

Auricular Acupuncture for Sleep Disorders

N/A
Recruiting
Led By Paul Crawford, MD
Research Sponsored by Paul Crawford
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PROMIS-16 Sleep-Related Impairment Scale with a score of medium or severe (T-Score greater than or equal to 60)
Be older than 18 years old
Must not have
Greater than 10 mg equivalent of diazepam per day for any reason
Non-response to greater than 2 PTSD treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 10 (23-24 weeks)

Summary

This trial is testing whether a specific protocol of auricular acupuncture can help people with sleep disturbances, and whether it can also decrease severity of anxiety, depression, pain and improve sleep and social functioning in people with mental health disorders.

Who is the study for?
This trial is for active duty members and DoD beneficiaries aged 18-80 at Nellis Air Force Base with sleep disturbances, as indicated by a specific score on the PROMIS-16 Sleep Scale. It's not for those with untreated sleep apnea, psychosis, unstable thyroid disease, depression with suicidality, high diazepam use, non-response to PTSD treatments over two times, recent unrelated acupuncture or pregnancy.
What is being tested?
The study tests auricular acupuncture against standard treatment for improving sleep in military personnel. Participants are randomly assigned to receive either the acupuncture protocol or standard care to see if it reduces symptoms of anxiety, depression and pain while improving sleep and social functioning.
What are the potential side effects?
While the information provided does not specify side effects of auricular acupuncture directly, common ones may include minor bleeding or bruising at needle sites, dizziness or fainting during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My sleep problems are medium to severe according to the PROMIS-16.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I take more than 10 mg of diazepam or its equivalent daily.
Select...
I have tried more than 2 treatments for PTSD without success.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 10 (23-24 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 10 (23-24 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Measure Yourself Medical Outcome Profile (MYMOP) Initial
PROMIS Sleep-Related Impairment Scale
Secondary study objectives
Couples Satisfaction Index CSI)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard treatment from PCM or Mental Health or both + auricular acupunctureExperimental Treatment1 Intervention
Group II: Standard treatment from Primary Care Manager (PCM) or Mental Health or bothPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auricular acupuncture
2013
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

Paul CrawfordLead Sponsor
5 Previous Clinical Trials
651 Total Patients Enrolled
Paul Crawford, MDPrincipal InvestigatorUniformed Services University of the Health Sciences
5 Previous Clinical Trials
1,198 Total Patients Enrolled

Media Library

Auricular Acupuncture (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04956341 — N/A
Insomnia Research Study Groups: Standard treatment from Primary Care Manager (PCM) or Mental Health or both, Standard treatment from PCM or Mental Health or both + auricular acupuncture
Insomnia Clinical Trial 2023: Auricular Acupuncture Highlights & Side Effects. Trial Name: NCT04956341 — N/A
Auricular Acupuncture (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04956341 — N/A
~0 spots leftby Dec 2024
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