Interest of Auriculotherapy in the Management of Chronic Insomnia (NCT04471168) | Clinical Trial Compass
RecruitingNot Applicable
Interest of Auriculotherapy in the Management of Chronic Insomnia
France72 participantsStarted 2020-10-14
Plain-language summary
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (antidepr…
What they're measuring
1
Number of patients with improvement of insomnia after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)