Auricular acupuncture for Sleep Disorder

Mike O'Callaghan Military Medical Center, Nellis Air Force Base, NV
Sleep DisorderAuricular acupuncture - Device
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Sleep Disorder

Treatment Effectiveness

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: visit 10 (23-24 weeks)

visit 1 (0 weeks)
Measure Yourself Medical Outcome Profile (MYMOP) Initial
visit 10 (23-24 weeks)
Couples Satisfaction Index CSI)
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Week 24
PROMIS Sleep-Related Impairment Scale

Trial Safety

Trial Design

2 Treatment Groups

Standard treatment from PCM or Mental Health or both + auricular acupuncture
1 of 2
Standard treatment from Primary Care Manager (PCM) or Mental Health or both
1 of 2

Experimental Treatment

Non-Treatment Group

316 Total Participants · 2 Treatment Groups

Primary Treatment: Auricular acupuncture · Has Placebo Group · N/A

Standard treatment from PCM or Mental Health or both + auricular acupuncture
Device
Experimental Group · 1 Intervention: Auricular acupuncture · Intervention Types: Device
Standard treatment from Primary Care Manager (PCM) or Mental Health or both
Other
PlaceboComparator Group · 1 Intervention: Standard treatment · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auricular acupuncture
2013
Completed Phase 3
~890

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: visit 10 (23-24 weeks)

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to receive medical care at Nellis Air Force Base to take part in this study.
You are an active duty member or a beneficiary of the Department of Defense, between 18 and 80 years old, and you have trouble sleeping.
You have moderate to severe sleep-related impairment based on the PROMIS-16 Sleep-Related Impairment Scale with a score of 60 or higher.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.