Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT04471168
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04471168
Study Brief:
Protocol Section:
NCT04471168