Auricular Acupuncture for Sleep Disturbances
Running, not enrolling · Not applicable
Conditions studied: Sleep Disturbance
In brief
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.
Key facts
- Study ID
- NCT04956341
- Run by
- Paul Crawford
- People needed
- 180
- Starts
- 2022-05-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female Active Duty members and DoD beneficiaries ages 18-80 with complaints of sleep disturbances.
- PROMIS-16 Sleep-Related Impairment Scale with a score of medium or severe (T-Score greater than or equal to 60).
You may not qualify if…
- Patients with OSA who are prescribed CPAP/BiPAP and either do not use it or use it <70% of time per patient report.
- Investigators seek to exclude individuals with sleep-related medical or psychiatric conditions that are so severe as to render these patients inappropriate for treatment in primary care or simple mental health without psychiatry oversight or that acupuncture cannot be expected to have an effect on (e.g., thyroid disease). Specifically, exclusion criteria will include:
- Psychosis
- Thyroid disease undergoing active adjustment of medication.Depression, with suicidality. (clinician judgment)
- Greater than 10 mg equivalent of diazepam equivalent per day for any reason
- Non-response to greater than 2 PSTD treatments
- Having acupuncture not related to sleep in the past 3 months
- Pregnant
Where it is running
- Mike O'Callaghan Military Medical Center — Nellis Air Force Base, Nevada, United States
Full record on ClinicalTrials.gov
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