Auricular Acupuncture for Sleep Disorders
Recruiting in Palo Alto (17 mi)
Overseen byPaul Crawford, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Paul Crawford
Must not be taking: Diazepam, others
Disqualifiers: OSA, Psychosis, Thyroid disease, others
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are taking more than 10 mg of diazepam (a medication for anxiety) per day, you may not be eligible to participate.
What data supports the effectiveness of the treatment Auricular Acupuncture for sleep disorders?
Research shows that auricular acupuncture can help improve sleep quality in people with insomnia, especially in older adults, and its effects can last for about two weeks. It has been found to increase sleep duration and reduce the time it takes to fall asleep, although these benefits may not last long-term.
12345Is auricular acupuncture safe for humans?
Auricular acupuncture is generally considered safe for humans, with rare complications such as pain at the needle site, minor bleeding, local tenderness, dizziness, and nausea, which are usually temporary.
35678How is auricular acupuncture treatment different from other treatments for sleep disorders?
Auricular acupuncture is unique because it involves stimulating specific points on the ear to help with sleep disorders, unlike other treatments that might involve medication or body acupuncture. This method is based on the idea that the ear contains points that correspond to different parts of the body, and stimulating these can help relieve symptoms like insomnia.
135910Eligibility Criteria
This trial is for active duty members and DoD beneficiaries aged 18-80 at Nellis Air Force Base with sleep disturbances, as indicated by a specific score on the PROMIS-16 Sleep Scale. It's not for those with untreated sleep apnea, psychosis, unstable thyroid disease, depression with suicidality, high diazepam use, non-response to PTSD treatments over two times, recent unrelated acupuncture or pregnancy.Inclusion Criteria
I am between 18-80 years old, serve in the military or am a DoD beneficiary, and have trouble sleeping.
Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study
My sleep problems are medium to severe according to the PROMIS-16.
Exclusion Criteria
I have had acupuncture for reasons other than sleep in the last 3 months.
I take more than 10 mg of diazepam or its equivalent daily.
I have depression with thoughts of harming myself.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Treatment
Participants receive auricular acupuncture or standard treatment over multiple visits
23-24 weeks
10 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Crossover
Participants in the non-acupuncture group still experiencing symptoms are offered acupuncture treatment
Not specified
Participant Groups
The study tests auricular acupuncture against standard treatment for improving sleep in military personnel. Participants are randomly assigned to receive either the acupuncture protocol or standard care to see if it reduces symptoms of anxiety, depression and pain while improving sleep and social functioning.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard treatment from PCM or Mental Health or both + auricular acupunctureExperimental Treatment1 Intervention
Group II: Standard treatment from Primary Care Manager (PCM) or Mental Health or bothPlacebo Group1 Intervention
Auricular Acupuncture is already approved in China, European Union, United States for the following indications:
🇨🇳 Approved in China as Auricular Acupuncture for:
- Pain relief
- Postoperative analgesia
- Osteoarthritis
🇪🇺 Approved in European Union as Auricular Acupuncture for:
- Pain relief
- Postoperative analgesia
🇺🇸 Approved in United States as Auricular Acupuncture for:
- Pain relief
- Postoperative analgesia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mike O'Callaghan Military Medical CenterNellis Air Force Base, NV
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Who Is Running the Clinical Trial?
Paul CrawfordLead Sponsor
References
Auricular acupuncture for insomnia: a systematic review. [2022]Auricular acupuncture (AA) is a therapeutic method by which specific points on the auricle are stimulated to treat various conditions. AA is often recommended as treatment for insomnia. The aim of this systematic review was to evaluate data from randomised, placebo-controlled clinical trials testing the effectiveness of AA for treating insomnia.
Auricular acupuncture for insomnia: duration and effects in Korean older adults. [2019]This study examined the duration and effects of auricular acupuncture on insomnia in a sample of 28 Korean older adults. The design was a group, pretest-posttest, repeated-measures study. Measures were the Sleep State Tool and the Sleep Satisfaction Tool. The effects of auricular acupuncture on insomnia among Korean older adults were significant. The duration effects of auricular acupuncture were maintained for 2 weeks. Clinicians should consider providing auricular acupuncture as an alternative method for improving quality of sleep in older adults.
Auricular acupuncture treatment for insomnia: a systematic review. [2022]To review trials on the efficacy and safety of auricular acupuncture (AA) treatment for insomnia and to identify the most commonly used auricular acupoints for treating insomnia in the studies via a frequency analysis.
Sleep patterns in a randomized controlled trial of auricular acupuncture and cognitive behavioral therapy for insomnia. [2018]The aim of the study was to objectively examine how sleep patterns were affected in a short- and long-term perspective after auricular acupuncture (AA) and cognitive behavioral therapy for insomnia (CBT-i). Sixty participants with insomnia disorders (men/women 9/51; mean age of 60.5 years, (SD 9.4)), were randomized to group treatment with AA or CBT-i. Actigraphy recordings were made at baseline, post-treatment and 6-month follow-up. The CBT-i group reduced their time in bed, their actual sleeping time, their sleep latency and their actual time awake. The AA group slept longer, increased their time in bed and decreased their sleep latency post-treatment. The between-groups results differed in wake-up time, rising, time in bed, actual sleep time and actual wake time. The differences were not maintained six months later. In accordance with previous findings the results support the notion that the objective sleep time does not necessarily affect the subjective perception of insomnia.
Effect of Auricular Acupuncture on the Reduction of Symptoms Related to Sleep Disorders, Anxiety and Temporomandibular Disorder (TMD). [2022]Auricular acupuncture (AA) is a complementary/integrative therapy, and can be used as adjuvant treatment in sleep disorders, anxiety and the painful symptomatology of temporomandibular disorders (TMDs).
[Systematic review and Meta-analysis on the auriculotherapy in treatment of insomnia]. [2023]To review the effectiveness and safety of auriculotherapy in treatment of insomnia.
Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. [2023]Label="Background" NlmCategory="UNASSIGNED">Auricular acupuncture (AA) is commonly used by acupuncturists as stand-alone therapy or as an adjunctive to body acupuncture. AA is considered to be safe, with rare complications. The most commonly reported complications are usually transient and include: pain at insertion; minor bleeding; local tenderness; dizziness; and nausea. No reported cases of an Aiguille Semi-Permanente® (ASP®) needle retained in the external auditory canal (EAC) has been found in the medical literature.
Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. [2021]Auricular acupuncture (AA) and extended auricular therapy (AT) are a part of acupuncture practice shown to benefit patients with pain, anxiety, and other conditions, with cost-effective access enhanced when given in a group setting. Yet there are safety concerns and risks, perhaps unnecessary risks, that attend embedded, indwelling needles applied to the ear as a means of extended AT.
Ear acupuncture in European traditional medicine. [2023]Auricular acupuncture is a diagnostic and treatment system based on normalizing the body's dysfunction through stimulation of definite points on the ear. Rudimentary forms of acupuncture which probably arose during the Stone Age have survived in many parts of the world right down to present day. It was used in the ancient Egypt, Rome, Greece and all the Mediterranean area. It is a microacupuncture technique similar to reflexology, and was first described in France in 1950 by Paul Nogier who is considered the Father of modern ear acupuncture. It was speculated that the technique works because groups of pluripotent cells contain information from the whole organism and create regional organization centers representing different parts of the body. Nevertheless stimulation of a reflex point in the ear seems relieve symptoms of distant pathologies. Modern research is confirming the efficacy of ear acupuncture for analgesia and anxiety related disease, while tobacco dependence and other substance abuse still need confirmation. Actually main methodological problems with auricular acupuncture are that exist too many maps with little agreement regarding point location in the ear, and that the correspondence or reflex systems does not correlated with modern knowledge of anatomy and physiology.
Comparison of Body, Auricular, and Abdominal Acupuncture Treatments for Insomnia Differentiated as Internal Harassment of Phlegm-Heat Syndrome: An Orthogonal Design. [2020]Objective. To identify the optimum treatment protocol for insomnia among auricular, body, and abdominal needling methods. Methods. A three-factor (3 needling protocols) and three-level experimental scheme was designed based on orthogonal method. 54 patients of insomnia differentiated as internal harassment of phlegm-heat syndrome were given two courses of acupuncture treatment (each with 20 times of acupuncture). The therapeutic effects were evaluated by comparing the Pittsburgh sleep quality index (PSQI), Hamilton Depression Scale (HAMD) scores, and Hamilton Anxiety Scale (HAMA) scores of patients before treatment, after one course of treatment, and after two courses of treatment as well as one month after treatment. Results. Body, auricular, and abdominal acupuncture treatments all alleviated symptoms of insomnia, depression, and anxiety, but body and auricular acupuncture had stronger therapeutic effects. Conclusions. Body acupuncture at basic points shall be given priority in protocol selection for insomnia. The second-best choice is auricular acupuncture with basic points combined with points based on Traditional Chinese Medicine (TCM) theories. Abdominal needling with very quick effect can be an alternative protocol with basic points combined with syndrome differentiation points.