Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT04471168

Interest of Auriculotherapy in the Management of Chronic Insomnia

Led by Hopital Foch · Updated on 2025-04-03

72

Participants Needed

4

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Interest of Auriculotherapy in the Management of Chronic Insomnia

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suffering from chronic insomnia as defined in the diagnostic and statistical manual of mental disorders (DSM-5)
  • Score 215 on the Insomnia Severity Index (ISI) questionnaire
  • Covered by a national healthcare insurance
  • Consent form signed
Not Eligible

You will not qualify if you...

  • 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 25
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Espace Santé Simone Veil

Issy-les-Moulineaux, Hauts de Seine, France, 97132

Actively Recruiting

2

Cabinet Médical Nouvelle France

Le Chesnay, Yvelines, France, 78158

Active, Not Recruiting

3

Cabinet de l'Olivier

Montigny-le-Bretonneux, Yvelines, France, 78423

Active, Not Recruiting

4

Hopital Foch

Suresnes, France, 92150

Actively Recruiting

Loading map...

Research Team

M

Mireille Michel-Cherqui, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Interest of Auriculotherapy in the Management of Chronic Insomnia | DecenTrialz