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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 10 (23-24 weeks)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My sleep problems are medium to severe according to the PROMIS-16.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 10 (23-24 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 10 (23-24 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Measure Yourself Medical Outcome Profile (MYMOP) Initial
PROMIS Sleep-Related Impairment Scale
Secondary outcome measures
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
~1030
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had acupuncture for reasons other than sleep in the last 3 months.I am between 18-80 years old, serve in the military or am a DoD beneficiary, and have trouble sleeping.I take more than 10 mg of diazepam or its equivalent daily.I have depression with thoughts of harming myself.My thyroid medication is currently being adjusted.I have tried more than 2 treatments for PTSD without success.My sleep problems are medium to severe according to the PROMIS-16.
Research Study Groups:
This trial has the following groups:- Group 1: Standard treatment from Primary Care Manager (PCM) or Mental Health or both
- Group 2: Standard treatment from PCM or Mental Health or both + auricular acupuncture
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate figure of participants in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical study's recruitment period began on May 1st of 2022 and was recently updated on June 6th 2022. A total of 316 participants are needed for the trial at a single site."
Answered by AI
Is the enrollment process for this trial still available?
"As detailed on clinicaltrials.gov, the recruitment process for this trial is in full swing and has been so since May 1st 2022 when it was first posted. The study's information was last edited on June 6th 2022."
Answered by AI
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