Study Summary
This trial is testing whether a specific protocol of auricular acupuncture can help people with sleep disturbances, and whether it can also decrease severity of anxiety, depression, pain and improve sleep and social functioning in people with mental health disorders.
Eligible Conditions
- Sleep Disorder
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
3 Primary · 1 Secondary · Reporting Duration: visit 10 (23-24 weeks)
visit 1 (0 weeks)
Measure Yourself Medical Outcome Profile (MYMOP) Initial
visit 10 (23-24 weeks)
Couples Satisfaction Index CSI)
Measure Yourself Medical Outcome Profile (MYMOP) Follow-up
Week 24
PROMIS Sleep-Related Impairment Scale
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
Standard treatment from PCM or Mental Health or both + auricular acupuncture
1 of 2
Standard treatment from Primary Care Manager (PCM) or Mental Health or both
1 of 2
Experimental Treatment
Non-Treatment Group
316 Total Participants · 2 Treatment Groups
Primary Treatment: Auricular acupuncture · Has Placebo Group · N/A
Standard treatment from PCM or Mental Health or both + auricular acupuncture
Device
Experimental Group · 1 Intervention: Auricular acupuncture · Intervention Types: DeviceStandard treatment from Primary Care Manager (PCM) or Mental Health or both
Other
PlaceboComparator Group · 1 Intervention: Standard treatment · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auricular acupuncture
2013
Completed Phase 3
~890
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: visit 10 (23-24 weeks)
Who is running the clinical trial?
Paul CrawfordLead Sponsor
5 Previous Clinical Trials
652 Total Patients Enrolled
Paul Crawford, MDPrincipal InvestigatorUniformed Services University of the Health Sciences
5 Previous Clinical Trials
1,198 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be able to receive medical care at Nellis Air Force Base to take part in this study.
You are an active duty member or a beneficiary of the Department of Defense, between 18 and 80 years old, and you have trouble sleeping.
You have moderate to severe sleep-related impairment based on the PROMIS-16 Sleep-Related Impairment Scale with a score of 60 or higher.
References
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- Van Camp RO. Zolpidem in fatigue management for surge operations of remotely piloted aircraft. Aviat Space Environ Med. 2009 Jun;80(6):553-5. doi: 10.3357/asem.2460.2009.
- Connor KM, Davidson JR. SPRINT: a brief global assessment of post-traumatic stress disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):279-84. doi: 10.1097/00004850-200109000-00005.
- Mohd Azmi NAS, Juliana N, Mohd Fahmi Teng NI, Azmani S, Das S, Effendy N. Consequences of Circadian Disruption in Shift Workers on Chrononutrition and their Psychosocial Well-Being. Int J Environ Res Public Health. 2020 Mar 19;17(6):2043. doi: 10.3390/ijerph17062043.
- Engdahl B, Dikel TN, Eberly R, Blank A Jr. Posttraumatic stress disorder in a community group of former prisoners of war: a normative response to severe trauma. Am J Psychiatry. 1997 Nov;154(11):1576-81. doi: 10.1176/ajp.154.11.1576.
- Oosterman JE, Wopereis S, Kalsbeek A. The Circadian Clock, Shift Work, and Tissue-Specific Insulin Resistance. Endocrinology. 2020 Dec 1;161(12):bqaa180. doi: 10.1210/endocr/bqaa180.
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- Moore BA, Tison LM, Palacios JG, Peterson AL, Mysliwiec V. Incidence of insomnia and obstructive sleep apnea in active duty United States military service members. Sleep. 2021 Jul 9;44(7):zsab024. doi: 10.1093/sleep/zsab024.
- Colvonen PJ, Straus LD, Stepnowsky C, McCarthy MJ, Goldstein LA, Norman SB. Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD. Curr Psychiatry Rep. 2018 Jun 21;20(7):48. doi: 10.1007/s11920-018-0916-9.
- Neylan TC, Marmar CR, Metzler TJ, Weiss DS, Zatzick DF, Delucchi KL, Wu RM, Schoenfeld FB. Sleep disturbances in the Vietnam generation: findings from a nationally representative sample of male Vietnam veterans. Am J Psychiatry. 1998 Jul;155(7):929-33. doi: 10.1176/ajp.155.7.929.
- Paul Crawford 2022. "Auricular Acupuncture for Sleep Disturbances". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04956341.
Frequently Asked Questions
What is the aggregate figure of participants in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical study's recruitment period began on May 1st of 2022 and was recently updated on June 6th 2022. A total of 316 participants are needed for the trial at a single site." - Anonymous Online Contributor
Unverified Answer
Is the enrollment process for this trial still available?
"As detailed on clinicaltrials.gov, the recruitment process for this trial is in full swing and has been so since May 1st 2022 when it was first posted. The study's information was last edited on June 6th 2022." - Anonymous Online Contributor
Unverified Answer