Interest of Auriculotherapy in the Management of Chronic Insomnia

Launched by HOPITAL FOCH · Jul 9, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a treatment called auriculotherapy for people suffering from chronic insomnia, which means difficulty sleeping that lasts a long time. Auriculotherapy involves stimulating specific points on the ear, and the researchers want to see if this method can help improve sleep quality. The study is currently looking for participants aged between 65 and 75 who meet certain criteria, including having a significant level of insomnia as measured by a questionnaire.

To participate, individuals must be struggling with chronic insomnia, have a score of 15 or higher on the Insomnia Severity Index, and be covered by national healthcare insurance. However, there are some exclusions, such as being pregnant, having certain psychiatric disorders, or recently starting specific medications that may affect sleep. Participants can expect to receive auriculotherapy sessions and will be asked to fill out questionnaires about their sleep throughout the study. This trial aims to provide insights into a potentially helpful treatment for those who have trouble sleeping.

Gender

ALL

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.