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Auricular Acupuncture for Sleep Disturbances

NCT04956341 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-01-12

No results posted yet for this study

Summary

A randomized controlled trial of auricular acupuncture for sleep disturbances.

* Objective 1: Evaluate the effectiveness of a specific protocol of auricular acupuncture in the treatment of sleep disturbance among active duty and otherDoD beneficiaries.
* Objective 2: Test whether a brief course of auricular acupuncture treatments among active duty and other DoD beneficiaries with sleep disturbance willalso decrease severity of anxiety, depression, pain and improve sleep and social functioning in subgroup analysis of subjects with known or newlydiagnosed mental health disorders (e.g., anxiety disorders, depression).
* Null Hypothesis: Auricular Acupuncture has no effect on sleep disturbance.
* Alternative Hypothesis: Auricular Acupuncture reduces sleep disturbance.

Conditions

  • Sleep Disturbance

Interventions

DEVICE

Auricular acupuncture

Auricular acupuncture treatments will be utilizing ASP needles. The needles will stay in and fall out on their own (usually 3-10 days). For some patients who are acupuncture naïve, Seirin 15mm needles will be placed and allowed to remain for 45 minutes. This option will be provided to all subjects for their first treatment. Auricular acupuncture treatment possible locations will be as defined as: Master Cerebral/Prefrontal cortex, Amygdala, Hippocampus, Hypothalamus, Point Zero, Shen Men, Insomnia 1,Insomnia 2 OR Prefrontal Cortex, Reticular formation, Pineal gland, Hypothalamus, Point zero. In acupuncture parlance, the patient will be treated with ATP plus sleep I on first visit, then the acupuncturist will continue to use that treatment for each subsequent visit with the potential to add ATP plus sleep II. Both ears will be treated unless the patient requests that one be left open. The acupuncturist may use sleep I in one ear and sleep II in the other.

OTHER

Standard treatment

Standard treatment from Primary Care Manager (PCM) or Mental Health or both

Sponsors & Collaborators

  • Paul Crawford

    lead FED

Principal Investigators

  • Paul Crawford, MD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04956341 on ClinicalTrials.gov