Status:
RECRUITING
Interest of Auriculotherapy in the Management of Chronic Insomnia
Lead Sponsor:
Hopital Foch
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.
Detailed Description
Chronic insomnia affects a significant proportion of the French population with an estimated prevalence between 15% and 20%. This disease is mainly managed by general practitioners for whom benzodiaz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 14 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04471168
Start Date
October 14 2020
End Date
October 14 2025
Last Update
April 3 2025
Active Locations (4)
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1
Espace Santé Simone Veil
Issy-les-Moulineaux, Hauts de Seine, France, 97132
2
Cabinet Médical Nouvelle France
Le Chesnay, Yvelines, France, 78158
3
Cabinet de l'Olivier
Montigny-le-Bretonneux, Yvelines, France, 78423
4
Hopital Foch
Suresnes, France, 92150