Clinical trial NCT04956341: Auricular Acupuncture for Sleep Disturbances
Official title: Auricular Acupuncture for Sleep Disturbances: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Keywords: acupuncture
auricular acupuncture
sleep
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2021-07-09
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: At Visit 10 (final visit), those in the non-acupuncture group still experiencing symptoms will be offered the opportunity to be rolled into the acupuncture 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 having symptoms they will be referred back to their primary care manager for further evaluation at the conclusion of the study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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:

* Obtain and document signed Informed Consent document and HIPAA Authorization.
* Review past medical history to verify the inclusion/exclusion criteria
* We will record health care resource utilization to include Number of hospital or clinic visits (previous encounters) for sleep problems in the past 12 months
* Medication use (Sleep medications, stimulant medications, energy drinks at least once/week), co-morbidities, phone number, e-mail address, dateof birth, gender, race, ethnicity, highest education level, total number of children in household), Service characteristics (officer, enlisted, retired)(service branch), History of deployment (never deployed, previously deployed, number of deployments), Usual Work pattern (Day, night),
* Record whether the subject has a history of Obstructive Sleep Apnea (OSA) and whether it is treated or untreated. If treated, do they use aContinuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) machine? If patient uses CPAP/BiPAP, do they use it atleast 70% of the time as reported by patient or CPAP/BiPAP recent data pull in medical record. These questions are asked due to a possiblerelationship between OSA and sleep disturbance (3); those who have OSA and do not use a CPAP or use one infrequently need to be accounted forso as to not to confound data analysis.
* PROMIS-16 Sleep-Related Impairment Scale

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:

* Group 1: Standard treatment from Primary Care Manager (PCM) or Mental Health or both
* Group 2: Standard treatment from PCM or Mental Health or both + auricular Acupuncture

Visit 1 (0 weeks may be same day as screening visit):

* 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.
* All subjects will be given a Couples Satisfaction Index-4 (CSI-4) business card and asked to have their closest family member/friend aged 18 yearsor older complete the questionnaire on Survey Monkey at Visit 1, Visit 8, and Visit 10 (the dates will be on the back of the CSI-4 business card).They will be asked to have the same person complete all 3 questionnaires during the study.
* All subjects will take the following questionnaires via study electronic device or paper:
* PROMIS-16 Sleep-Related Impairment Scale (PROMIS-16)
* Measure Yourself Medical Outcome Profile (MYMOP) Initial

Visit 2 (1 week):

* 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.

Visit 3 (2 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.

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:

  * PROMIS-16
  * MYMOP Follow Up

Visit 5 (5 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.

Visit 6 (7 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.

Visit 7 (9 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.

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:

  * PROMIS-16
  * MYMOP Follow Up
* 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:

  * PROMIS-16
  * MYMOP Follow Up

Visit 10 (23-24 Weeks):

* All subjects will take the following questionnaires via study electronic device or paper:

  * PROMIS-16
  * MYMOP Follow Up
* 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

Eligibility 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

Primary outcomes:
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: baseline, pre-intervention
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 1 (0 weeks/same day as screening)
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 2 (1 week) post study visit procedures appropriate to subject randomization group
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 3 (2 weeks) post study visit procedures appropriate to subject randomization group
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 4 (3 weeks) post study visit procedures appropriate to subject randomization group
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 5 (5 weeks) post study visit procedures appropriate to subject randomization group
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 6 (7 weeks) post study visit procedures appropriate to subject randomization group
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 7 (9 weeks) post study visit procedures appropriate to subject randomization group
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 8 (11 weeks) post study visit procedures appropriate to subject randomization group
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 9 (15 weeks) post study visit procedures appropriate to subject randomization group
measure: PROMIS Sleep-Related Impairment Scale
timeFrame: visit 10 (23-24 weeks) post study visit procedures appropriate to subject randomization group
measure: Measure Yourself Medical Outcome Profile (MYMOP) Initial
timeFrame: visit 1 (0 weeks)
measure: Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
timeFrame: visit 4 (3 weeks)
measure: Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
timeFrame: visit 8 (11 weeks)
measure: Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
timeFrame: visit 9 (15 weeks)
measure: Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
timeFrame: visit 10 (23-24 weeks)
Secondary outcomes:
measure: Couples Satisfaction Index CSI)
timeFrame: visit 1 (0 weeks)
measure: Couples Satisfaction Index CSI)
timeFrame: visit 8 (11 weeks)
measure: Couples Satisfaction Index CSI)
timeFrame: visit 10 (23-24 weeks)
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Paul Crawford, MD
role: PRINCIPAL_INVESTIGATOR
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