Auricular Acupuncture for Sleep Disorders

Overseen By Jill M Clark, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Paul Crawford

Must not be taking: Diazepam, others

Disqualifiers: OSA, Psychosis, Thyroid disease, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 23-24 weeks

316 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{3 5 6 7 8}

How 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. ^{1 3 5 9 10}

Research Team

Paul Crawford, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Eligibility 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.

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

Treatment Details

Interventions

• Auricular Acupuncture

Trial Overview 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.

Participant Groups

Group I: Standard treatment from PCM or Mental Health or both + auricular acupuncture Experimental Treatment 1 Intervention

Group II: Standard treatment from Primary Care Manager (PCM) or Mental Health or both Placebo Group 1 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

Who Is Running the Clinical Trial?

Paul Crawford

Lead Sponsor

Trials

6

Recruited

970+

Findings from Research

A systematic review of 10 randomized controlled trials (RCTs) on auricular acupuncture (AA) for insomnia found some evidence suggesting that magnetic pellet AA may improve sleep efficiency compared to placebo, but overall methodological quality of the studies was poor.

The evidence for AA's effectiveness in treating insomnia is limited, as one RCT with needle AA showed no effectiveness, highlighting the need for more rigorously designed trials to confirm any potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for insomnia: a systematic review. Lee, MS., Shin, BC., Suen, LK., et al.[2022]

Auricular acupuncture significantly improved insomnia symptoms in a study of 28 older Korean adults, indicating its potential as an effective treatment for sleep issues.

The positive effects of auricular acupuncture on sleep quality were sustained for up to 2 weeks after treatment, suggesting lasting benefits for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for insomnia: duration and effects in Korean older adults. Kim, KB., Sok, SR.[2019]

Auricular acupuncture (AA) has been found to be effective in treating insomnia, showing higher recovery and improvement rates compared to diazepam, based on a meta-analysis of 6 trials involving 673 participants.

The most commonly used acupoints for insomnia treatment were identified, with Shenmen being the most frequently targeted, indicating specific areas may enhance the efficacy of AA for improving sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture treatment for insomnia: a systematic review. Chen, HY., Shi, Y., Ng, CS., et al.[2022]

In a study of 60 participants with insomnia, cognitive behavioral therapy for insomnia (CBT-i) led to significant improvements in sleep patterns, including reduced time in bed and sleep latency, while auricular acupuncture (AA) resulted in longer sleep duration and increased time in bed post-treatment.

However, the benefits of both treatments were not sustained at the six-month follow-up, suggesting that while both interventions can improve sleep in the short term, their long-term effectiveness may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep patterns in a randomized controlled trial of auricular acupuncture and cognitive behavioral therapy for insomnia. Bergdahl, L., Broman, JE., Berman, AH., et al.[2018]

Auricular acupuncture (AA) significantly reduced symptoms of sleep disorders in patients aged 20 to 45, as evidenced by a statistically significant difference in scores after 8 weeks of treatment (P = .014).

While AA showed some relief in anxiety and TMD pain symptoms, these results were not statistically significant, indicating that AA may be more effective for sleep disorders than for anxiety or TMD pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Auricular Acupuncture on the Reduction of Symptoms Related to Sleep Disorders, Anxiety and Temporomandibular Disorder (TMD). Cândido Dos Reis, A., Theodoro de Oliveira, T., Vidal, CL., et al.[2022]

Auriculotherapy is more effective than traditional western medications, conventional acupuncture, and Chinese herbal medicine in treating insomnia, with a significant improvement in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI).

This therapy also has fewer adverse effects compared to western medications, suggesting it may be a safer alternative for insomnia treatment, although further high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic review and Meta-analysis on the auriculotherapy in treatment of insomnia]. Jiao, Y., Han, Y., Zhou, JC., et al.[2023]

Auricular acupuncture (AA) is generally safe, but this case report highlights a rare occurrence where an Aiguille Semi-Permanente® (ASP®) needle was found retained in a patient's external auditory canal after treatment for complex regional pain syndrome.

Acupuncturists should be vigilant for potential complications, such as a foreign-body sensation in the ear, and conduct examinations if patients report unusual symptoms following AA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. Kazal, LA.[2023]

Auricular acupuncture and extended auricular therapy can effectively help with pain and anxiety, but using embedded needles poses significant safety risks, including infections and chondritis, as highlighted by 19 adverse event case reports and multiple safety reviews.

Extended auricular therapy using non-invasive methods, like applying natural seeds, offers similar clinical benefits without the risks associated with embedded needles, suggesting a need for further research to determine the necessity of needle use in auricular treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. Nielsen, A., Gereau, S., Tick, H.[2021]

Auricular acupuncture, a technique that stimulates specific points on the ear, has historical roots and is gaining modern support for its effectiveness in relieving pain and anxiety-related conditions.

Despite its potential benefits, there are significant methodological challenges in auricular acupuncture research, including inconsistent point location maps and a lack of correlation with current anatomical and physiological understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ear acupuncture in European traditional medicine. Gori, L., Firenzuoli, F.[2023]

In a study involving 54 patients with insomnia, body and auricular acupuncture treatments were found to be more effective than abdominal acupuncture in alleviating symptoms of insomnia, depression, and anxiety after two courses of treatment.

The results suggest that body acupuncture should be prioritized in treatment protocols for insomnia, while auricular acupuncture is a strong second option, indicating a clear hierarchy in the effectiveness of these acupuncture methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Body, Auricular, and Abdominal Acupuncture Treatments for Insomnia Differentiated as Internal Harassment of Phlegm-Heat Syndrome: An Orthogonal Design. Jiao, Y., Han, Y., Li, X., et al.[2020]

References

1. India pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for insomnia: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for insomnia: duration and effects in Korean older adults. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Auricular acupuncture treatment for insomnia: a systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Sleep patterns in a randomized controlled trial of auricular acupuncture and cognitive behavioral therapy for insomnia. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Auricular Acupuncture on the Reduction of Symptoms Related to Sleep Disorders, Anxiety and Temporomandibular Disorder (TMD). [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Systematic review and Meta-analysis on the auriculotherapy in treatment of insomnia]. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Semi-Permanent Ear (Aguille SP) Needle "Migration" into the External Auditory Canal. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Ear acupuncture in European traditional medicine. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of Body, Auricular, and Abdominal Acupuncture Treatments for Insomnia Differentiated as Internal Harassment of Phlegm-Heat Syndrome: An Orthogonal Design. [2020]