RecruitingNot ApplicableNCT04471168
Interest of Auriculotherapy in the Management of Chronic Insomnia
Sponsor
Hopital Foch
Enrollment
72 participants
Start Date
Oct 14, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.
Eligibility
Min Age: 18 YearsMax Age: 64 Years
Inclusion Criteria4
- 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 Criteria14
- 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.
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Interventions
DEVICECryo-Auriculotherapy
3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
DEVICESham comparator
3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04471168
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