Actively Recruiting
Interest of Auriculotherapy in the Management of Chronic Insomnia
Led by Hopital Foch · Updated on 2025-04-03
72
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.
CONDITIONS
Official Title
Interest of Auriculotherapy in the Management of Chronic Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suffering from chronic insomnia as defined in the diagnostic and statistical manual of mental disorders (DSM-5)
- Score 215 on the Insomnia Severity Index (ISI) questionnaire
- Covered by a national healthcare insurance
- Consent form signed
You will not qualify if you...
- 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 25
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Espace Santé Simone Veil
Issy-les-Moulineaux, Hauts de Seine, France, 97132
Actively Recruiting
2
Cabinet Médical Nouvelle France
Le Chesnay, Yvelines, France, 78158
Active, Not Recruiting
3
Cabinet de l'Olivier
Montigny-le-Bretonneux, Yvelines, France, 78423
Active, Not Recruiting
4
Hopital Foch
Suresnes, France, 92150
Actively Recruiting
Research Team
M
Mireille Michel-Cherqui, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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