Using auriculotherapy to treat chronic insomnia
Interest of Auriculotherapy in the Management of Chronic Insomnia
This study is testing if a new ear treatment called cryo-auriculotherapy can help people with chronic insomnia sleep better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Hopital Foch Academic / other |
| Locations | 4 sites (Issy-les-Moulineaux, Hauts de Seine and 3 other locations) |
| Trial ID | NCT04471168 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of cryo-auriculotherapy in managing chronic insomnia, a condition affecting 15-20% of the French population. Participants diagnosed with chronic insomnia, based on DSM-5 criteria, will receive either cryo-auriculotherapy or a sham treatment in a controlled setting. The study will compare the outcomes of both groups to determine the efficacy of the treatment. The intervention involves the use of a device that administers nitrous oxide to stimulate specific points in the ear.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with chronic insomnia who have a score of 15 or higher on the Insomnia Severity Index.
Not a fit: Patients with unstable psychiatric disorders, those on certain medications, or individuals with specific sleep-related comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for patients suffering from chronic insomnia.
How similar studies have performed: While the use of auriculotherapy is gaining interest, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suffering from chronic insomnia as defined in the diagnostic and statistical manual of mental disorders (DSM-5) * Score ≥ 15 on the Insomnia Severity Index (ISI) questionnaire; * Covered by a national healthcare insurance * Consent form signed Exclusion Criteria: * Pregnant woman or pregnancy planned for the duration of the study; * Regular night work or shift work / reversal of sleep patterns; * Trans meridian travel during the previous month or planned during the study period; * Unstable or untreated psychiatric disorder including severe depression, severe addiction, unbalanced bipolar disorder; * Taking insomnia-inducing drugs (eg Corticoids); * Hypnotic treatment or antidepressant treatment with hypnotic aim introduced since less than 4 weeks or with change dating back less than 4 weeks; * Presence of organic comorbidities which may be responsible for sleep disorders (SAS and restless legs syndrome): (STOP-BANG) score ≥ 5; * History of central neurological disorders or progressive brain injury; * Contraindication to the use of auriculotherapy (lesion or infection of the pinna) by cryotherapy (skin scarring disorder, risk of hypo or hyperpigmentation); * Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months; * Previous treatment with cryo-auriculotherapy * Having started in the month preceding the first auriculotherapy session, any new treatment likely to interfere with the study: specific drug treatment (antidepressant, morphine or anticonvulsant) or complementary therapy (psychological care, physiotherapy, balneotherapy, etc.). * Difficulty complying with the treatment, questionnaire or study protocol. * Be deprived of liberty or under guardianship.
Where this trial is running
Issy-les-Moulineaux, Hauts de Seine and 3 other locations
- Espace Santé Simone Veil — Issy-les-Moulineaux, Hauts de Seine, France (Recruiting)
- Cabinet Médical Nouvelle France — Le Chesnay, Yvelines, France (Active_not_recruiting)
- Cabinet de l'Olivier — Montigny-le-Bretonneux, Yvelines, France (Active_not_recruiting)
- Hopital Foch — Suresnes, France (Recruiting)
Study contacts
- Principal investigator: Mireille Michel-Cherqui, MD — Hopital Foch
- Study coordinator: Mireille Michel-Cherqui, MD
- Email: m.michel-cherqui@hopital-foch.org
- Phone: +33(0)146252985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.