Informations générales (source: ClinicalTrials.gov)

NCT04471168 En recrutement IDF
Interest of Auriculotherapy in the Management of Chronic Insomnia (AURICULO-DODO)
Interventional
  • Troubles de l'endormissement et du maintien du sommeil
N/A
Hopital Foch (Voir sur ClinicalTrials)
octobre 2020
octobre 2025
04 avril 2025
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH MIREILLE MICHEL-CHERQUI En recrutement IDF 05/05/2025 07:12:07  Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
MSPU DE MONTIGNY LE BRETONNEUX Active, sans recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Cabinet Médical Nouvelle France - 78158 - Le Chesnay - Yvelines - France Active, sans recrutement Contact (sur clinicalTrials)
Espace Santé Simone Veil - 97132 - Issy-les-Moulineaux - Hauts De Seine - France Sabrina MA, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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



- 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.