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Completed NCT04471168

Interest of Auriculotherapy in the Management of Chronic Insomnia

Conditions: Chronic Insomnia

Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: NA
Enrollment: 65
Sponsor: Hopital Foch

Location: Espace Santé Simone Veil Issy-les-Moulineaux Hauts de Seine

Summary

The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04471168). StuddyBuddy aggregates publicly available trial information.