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A randomized controlled trial of auricular acupuncture for sleep disturbances.
Full description
Active duty members and DoD beneficiaries aged 18-80 years old and meeting the inclusion/exclusion criteria will be offered an opportunity to participate.They will be recruited from the clinics at 99MDG (Nellis AFB), 96MDG (Eglin AFB), and 375 MDG (Scott AFB). All of the below items are research-relatedunless marked as 'standard of care'. All visits will last approximately 30 minutes in length.
Screening Visit:
Randomization:
Subjects who score a medium or severe on the PROMIS-16 (T-Score greater than or equal to 60). Sleep-Related Impairment Scale will berandomized into one of two groups and the intervention will be performed. The investigators acknowledge that any of these standard treatmentsmay be shorter or longer in duration than the duration of the study. There is no additional risk to subjects for continuing to track their sleeppatterns and mental health scores on various instruments shorter or longer than standard of care treatments. Furthermore, this study is meant tobe a pragmatic trial-there are many evidence based and not evidence based treatments for sleep disturbance that are considered standard ofcare. We seek to allow any of these treatments to proceed and evaluate the addition of auricular acupuncture as it can be applied in a clinic setting:
Visit 1 (0 weeks may be same day as screening visit):
Visit 2 (1 week):
Visit 3 (2 weeks):
Visit 4 (3 weeks):
Subjects will receive study procedures according to their randomization group.
For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles -placed, and the location of the needles for each treatment.
All subjects will take the following questionnaires via study electronic device or paper:
Visit 5 (5 weeks):
Visit 6 (7 Weeks):
Visit 7 (9 weeks):
Visit 8 (11 weeks):
Subjects will receive study procedures according to their randomization group.
For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
All subjects will take the following questionnaires via study electronic device or paper:
Subjects will be reminded to have their closest family member/friend aged 18 years or older complete the on-line CSI-4 questionnaire on SurveyMonkey on the dates noted on the back of the CSI-4 Business Card. They will be given another CSI-4 business card, if needed.
Visit 9 (15 weeks):
Subjects will receive study procedures according to their randomization group.
For subjects in group 2, the Research Coordinator will record the name of the investigator performing the auricular acupuncture, the number ofASP acupuncture needles placed, and the location of the needles for each treatment.
All subjects will take the following questionnaires via study electronic device or paper:
Visit 10 (23-24 Weeks):
All subjects will take the following questionnaires via study electronic device or paper:
Subjects will be reminded to have their closest family member/friend aged 18 years or older complete the on-line CSI-4 questionnaire on SurveyMonkey on the dates noted on the back of the CSI-4 Business Card. They will be given another CSI-4 business card, if needed.
CROSSOVER:
At Visit 10 (final visit), those in the non-acupuncture group still experiencing symptoms will be offered the opportunity to be rolled into theacupuncture treatment arm of the study as outlined above. This will not be part of the analysis. If a patient in the acupuncture group is still havingsymptoms they will be referred back to their primary care manager for further evaluation at the conclusion of the study.
All study subjects will receive a $100 gift card at the completion of the 24 weeks. Active Duty and GS employees (who are also DoD beneficiaries) mayalso receive a $100 gift card only upon completion of the appropriate off-duty employment paperwork with their supervisor
Enrollment
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Inclusion and 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:
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:
Having acupuncture not related to sleep in the past 3 months
Pregnant
Primary purpose
Allocation
Interventional model
Masking
316 participants in 2 patient groups, including a placebo group
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Central trial contact
Jill M Clark, MBA
Data sourced from clinicaltrials.gov
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