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A randomized controlled trial of auricular acupuncture for sleep disturbances.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment from PCM or Mental Health or both + auricular acupuncture | Experimental |
| |
| Standard treatment from Primary Care Manager (PCM) or Mental Health or both | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular acupuncture | Device | Auricular acupuncture treatments will be utilizing ASP needles. The needles will stay in and fall out on their own (usually 3-10 days). For some patients who are acupuncture naïve, Seirin 15mm needles will be placed and allowed to remain for 45 minutes. This option will be provided to all subjects for their first treatment. Auricular acupuncture treatment possible locations will be as defined as: Master Cerebral/Prefrontal cortex, Amygdala, Hippocampus, Hypothalamus, Point Zero, Shen Men, Insomnia 1,Insomnia 2 OR Prefrontal Cortex, Reticular formation, Pineal gland, Hypothalamus, Point zero. In acupuncture parlance, the patient will be treated with ATP plus sleep I on first visit, then the acupuncturist will continue to use that treatment for each subsequent visit with the potential to add ATP plus sleep II. Both ears will be treated unless the patient requests that one be left open. The acupuncturist may use sleep I in one ear and sleep II in the other. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | baseline, pre-intervention |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 1 (0 weeks/same day as screening) |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score |
| Measure | Description | Time Frame |
|---|---|---|
| Couples Satisfaction Index CSI) | The CSI-4 is family member survey. CSI-4 scores can range from 0 to 21 and scores can be treated as a continuous variable. Higher scores indicate higher levels of relationship satisfaction. CSI-4 scores falling below 13.5 suggest notable relationship dissatisfaction. 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 years or older complete the questionnaire on Survey Monkey. |
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**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
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| Name | Affiliation | Role |
|---|---|---|
| Paul Crawford, MD | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Military Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25397825 | Background | Engel CC, Cordova EH, Benedek DM, Liu X, Gore KL, Goertz C, Freed MC, Crawford C, Jonas WB, Ursano RJ. Randomized effectiveness trial of a brief course of acupuncture for posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S57-64. doi: 10.1097/MLR.0000000000000237. | |
| 15229303 | Background | Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603. |
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We do not plan on sharing data.
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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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.
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|
| Standard treatment | Other | Standard treatment from Primary Care Manager (PCM) or Mental Health or both |
|
| visit 2 (1 week) post study visit procedures appropriate to subject randomization group |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 3 (2 weeks) post study visit procedures appropriate to subject randomization group |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 4 (3 weeks) post study visit procedures appropriate to subject randomization group |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 5 (5 weeks) post study visit procedures appropriate to subject randomization group |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 6 (7 weeks) post study visit procedures appropriate to subject randomization group |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 7 (9 weeks) post study visit procedures appropriate to subject randomization group |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 8 (11 weeks) post study visit procedures appropriate to subject randomization group |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 9 (15 weeks) post study visit procedures appropriate to subject randomization group |
| PROMIS Sleep-Related Impairment Scale | Computer Adaptive Test (CAT) version OR The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. As additional items from the 16-item bank are administered, the potential for error is reduced and confidence in the respondent's score increases. CAT will continue until either the standard error drops below a specified level (on the T-score metric 3.0 for adult and adult cancer CATs), or the participant has answered the maximum number of questions (12), whichever occurs first. Sleep Related Impairment- Short form 8a (paper version). Subjects must answer all items (questions/statements) presented for a valid score | visit 10 (23-24 weeks) post study visit procedures appropriate to subject randomization group |
| Measure Yourself Medical Outcome Profile (MYMOP) Initial | MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1. | visit 1 (0 weeks) |
| Measure Yourself Medical Outcome Profile (MYMOP) Follow-up | MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1. | visit 4 (3 weeks) |
| Measure Yourself Medical Outcome Profile (MYMOP) Follow-up | MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1. | visit 8 (11 weeks) |
| Measure Yourself Medical Outcome Profile (MYMOP) Follow-up | MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1. | visit 9 (15 weeks) |
| Measure Yourself Medical Outcome Profile (MYMOP) Follow-up | MYMOP employs a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score. Normative values are neither available nor meaningful for the MYMOP as it is individual to each patient; however, a clinically meaningful change is considered to be a change in the scores of more than 1. | visit 10 (23-24 weeks) |
| visit 1 (0 weeks) |
| Couples Satisfaction Index CSI) | The CSI-4 is family member survey. CSI-4 scores can range from 0 to 21 and scores can be treated as a continuous variable. Higher scores indicate higher levels of relationship satisfaction. CSI-4 scores falling below 13.5 suggest notable relationship dissatisfaction. 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 years or older complete the questionnaire on Survey Monkey. | visit 8 (11 weeks) |
| Couples Satisfaction Index CSI) | The CSI-4 is family member survey. CSI-4 scores can range from 0 to 21 and scores can be treated as a continuous variable. Higher scores indicate higher levels of relationship satisfaction. CSI-4 scores falling below 13.5 suggest notable relationship dissatisfaction. 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 years or older complete the questionnaire on Survey Monkey. | visit 10 (23-24 weeks) |
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