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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether auricular acupuncture, a type of ear acupuncture, can improve sleep problems. Besides sleep, the trial will assess if this treatment can ease anxiety, depression, and pain, and enhance social functioning for individuals with mental health issues. Participants will receive either standard care or standard care plus acupuncture. Suitable candidates include active duty members or other military beneficiaries who have trouble sleeping and can receive care at Nellis Air Force Base. As an unphased trial, this study provides a unique opportunity to investigate a potentially beneficial treatment for sleep and mental health issues.

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 prior data suggests that this protocol of auricular acupuncture is safe for treating sleep disturbances?

Research shows that ear acupuncture is generally safe. Past studies have identified mild side effects, such as soreness or pain at the needle site, dizziness, and minor bleeding. Some individuals also report discomfort in the area.

However, these side effects are usually not serious. Ear acupuncture has proven to be a safe and effective treatment for various issues, such as depression and sleep problems. It is considered a safe option for many and can be performed in a group setting, making it both time- and cost-efficient.

Overall, the treatment appears well-tolerated, with only minor and temporary side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Auricular acupuncture is unique because it offers a non-drug approach to tackling sleep disorders. Unlike typical treatments that often rely on medications like benzodiazepines or cognitive-behavioral therapy, this technique involves stimulating specific points on the ear to help improve sleep quality. Researchers are excited about this treatment because it may provide a natural alternative with potentially fewer side effects and can be easily integrated with existing mental health care practices.

What evidence suggests that auricular acupuncture is effective for sleep disturbances?

Research has shown that auricular acupuncture, which involves stimulating specific points on the ear, can improve sleep. Studies have found that this technique significantly reduces sleep problems and enhances overall sleep quality. In one study, participants who received auricular acupuncture showed better sleep according to a common sleep quality measure. Additionally, this method has reduced pain and boosted mood, factors often linked to sleep issues. In this trial, some participants will receive standard treatment from their Primary Care Manager or Mental Health provider, while others will receive standard treatment plus auricular acupuncture. These findings suggest that auricular acupuncture might be a helpful option for those dealing with sleep problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul Crawford, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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 (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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7244956/

Effectiveness of Auricular Acupuncture for Insomnia

Increasing evidence shows that auricular acupuncture (AA) can improve the sleep quality of insomnia. However, evidence quality has not been evaluated. ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590142725000217

Effectiveness of Acupressure at Different Ear Acupoints on ...

Both groups showed significant reductions in sleep disturbance, pain interference, and pain intensity (p<0.05). However, only the NT-APA group ...

3.

frontiersin.org

frontiersin.org/journals/sleep/articles/10.3389/frsle.2024.1323967/full

Effectiveness of applying auricular acupressure to treat ...

Network meta-analysis revealed that auricular point plasters could reduce PSQI scores and work in coordination with other therapies (Figure 7B).

4.

scielosp.org

scielosp.org/article/rsp/2025.v59/e27/en/

a clinical trial Efficacy of auricular acupuncture on sleep ...

We observed no statistically significant difference in sleep quality between individuals with depressive symptoms undergoing specific auricular ...

5.

e-jyms.org

e-jyms.org/journal/view.php?doi=10.12701/jyms.2022.00542

Auricular acupuncture for sleep quality in participants with ...

The results revealed a positive effect of AA (by the NADA-Acudetox protocol) on sleep quality (as measured by PSQI) among participants in a ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4241563/

Adverse Events of Auricular Therapy: A Systematic Review

For auricular acupuncture, the most frequently reported adverse events were tenderness or pain at insertion, dizziness, local discomfort, minor bleeding and ...

7.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2812388

Efficacy and Safety of Auricular Acupuncture for Depression

This randomized clinical trial analyzes the safety and efficacy of auricular acupuncture as a treatment for depression.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8394534/

Efficacy and Safety of Auricular Acupuncture for the Treatment ...

Two reviews showed auricular acupuncture to be a relatively safe, time- and cost-efficient intervention that can be offered in a group setting [ ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S0965229924001092

Effect of auriculotherapy on anxiety-fatigue and sleep ...

Group auricular acupuncture may be an effective and safe intervention for treating sleep problems in breast cancer survivors in the short term, and may also ...

10.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1496502/full

The efficacy and safety of auricular acupoint therapy on ...

This study aims to evaluate the clinical efficacy and safety of auriculotherapy in treating FD patients with insomnia.