Auricular acupuncture for improving sleep disturbances
Auricular Acupuncture for Sleep Disturbances: A Randomized Control Trial
This study is testing whether auricular acupuncture can help active duty military personnel and Department of Defense beneficiaries sleep better and feel less anxious or depressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 316 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mike O'Callaghan Military Hospital Federal |
| Locations | 1 site (Nellis Air Force Base, Nevada) |
| Trial ID | NCT04956341 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of auricular acupuncture in treating sleep disturbances among active duty military personnel and Department of Defense beneficiaries. Participants aged 18-80 will receive a specific protocol of acupuncture treatments, with the aim of reducing sleep issues and potentially alleviating associated conditions such as anxiety and depression. The study will involve screening visits to assess eligibility and gather relevant health information. The primary goal is to determine if acupuncture can significantly improve sleep quality compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates are active duty military members and DoD beneficiaries aged 18-80 experiencing sleep disturbances.
Not a fit: Patients with untreated obstructive sleep apnea or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological option for patients struggling with sleep disturbances.
How similar studies have performed: Other studies have shown promising results for acupuncture in treating sleep disturbances, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\* Inclusion Criteria: * 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). Exclusion Criteria: * 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 this trial is running
Nellis Air Force Base, Nevada
- Mike O'Callaghan Military Medical Center — Nellis Air Force Base, Nevada, United States (Recruiting)
Study contacts
- Principal investigator: Paul Crawford, MD — Uniformed Services University of the Health Sciences
- Study coordinator: Jill M Clark, MBA
- Email: jill.m.clark15.civ@mail.mil
- Phone: 7026533298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.