Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT03503695
Eligibility Criteria:
Inclusion Criteria:
* military beneficiary - active duty, retiree, or dependents
* between the ages of 18 - 65 years
* fall under the care of LRMC footprint
* self-report of insomnia based on established research criteria
* sleep-onset latency (SOL) or wakefulness after sleep onset of ≥30 minutes;
* frequency of at least three times a week;
* duration of ≥3 months;
* with unrestorative or unrefreshing sleep
* NRS Pain rating ≥3 (mild to severe level)
* pain for ≥3 months
* able to read and understand English
* for active duty military, an agreement of supervisor
Exclusion Criteria:
* hypersensitivity or allergy to gold.
* pregnancy or plan for future pregnancy during the duration of the study (since the safety of AA in pregnant women has not been established; based on self-report rather than requiring a pregnancy test)
* ear trauma or unhealed wounds on the ear
* participation in any other research protocol with a device or drugs
* piercing or scar tissue in any of the AA point areas
* working in jobs with variable hours (e.g., shift work)
* acupuncture treatment within the last 3 months
* individuals with valvular prosthetics, hemophilia, or currently receiving an anticoagulant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03503695
Study Brief:
Protocol Section:
NCT03503695