CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 180 enrolled
Drug / intervention
Auricular acupuncture +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04956341
NCT04956341N/AActive

Auricular Acupuncture for Sleep Disturbances: A Randomized Control Trial

Paul Crawford·interventional·Posted Jul 9, 2021·Updated Jan 12, 2026

In Brief

A clinical study evaluating Auricular acupuncture and Standard treatment for Sleep Disturbance. Active but no longer recruiting, targeting 180 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/AActive
202220232024202520262027
First PostedJul 9, 2021
Enrollment StartMay 1, 2022
Primary CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 5.0 years agoPrimary completion in 5 months

Interventions

Auricular acupuncturedevice

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.

Standard treatmentother

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