Auricular Acupuncture for Sleep Disturbances: A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- PROMIS Sleep-Related Impairment Scale
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Arms & Interventions
Standard treatment from PCM or Mental Health or both + auricular acupuncture
Intervention: Auricular acupuncture (Device)
Standard treatment from Primary Care Manager (PCM) or Mental Health or both
Intervention: Standard treatment (Other)
Outcomes
Primary Outcomes
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 10 (23-24 weeks) post study visit procedures appropriate to subject randomization group
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 Yourself Medical Outcome Profile (MYMOP) Follow-up
Time Frame: visit 10 (23-24 weeks)
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.
Measure Yourself Medical Outcome Profile (MYMOP) Initial
Time Frame: visit 1 (0 weeks)
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.
PROMIS Sleep-Related Impairment Scale
Time Frame: baseline, pre-intervention
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 1 (0 weeks/same day as screening)
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 2 (1 week) post study visit procedures appropriate to subject randomization group
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 3 (2 weeks) post study visit procedures appropriate to subject randomization group
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 4 (3 weeks) post study visit procedures appropriate to subject randomization group
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 5 (5 weeks) post study visit procedures appropriate to subject randomization group
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 6 (7 weeks) post study visit procedures appropriate to subject randomization group
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 7 (9 weeks) post study visit procedures appropriate to subject randomization group
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 8 (11 weeks) post study visit procedures appropriate to subject randomization group
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
PROMIS Sleep-Related Impairment Scale
Time Frame: visit 9 (15 weeks) post study visit procedures appropriate to subject randomization group
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 Yourself Medical Outcome Profile (MYMOP) Follow-up
Time Frame: visit 4 (3 weeks)
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.
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Time Frame: visit 8 (11 weeks)
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.
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Time Frame: visit 9 (15 weeks)
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.
Secondary Outcomes
- Couples Satisfaction Index CSI)(visit 10 (23-24 weeks))
- Couples Satisfaction Index CSI)(visit 1 (0 weeks))
- Couples Satisfaction Index CSI)(visit 8 (11 weeks))
Investigators
Paul Crawford
Principal Investigator
Mike O'Callaghan Military Hospital