Interest of Auriculotherapy in the Management of Chronic Insomnia

NCT04471168 | Recruiting

• 1 other identifier: 2018_0107
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Chronic Insomnia

Keywords

Cryo auriculotherapy

Outcome Measures

Primary Outcomes (1)

• Number of patients with improvement of insomnia after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)

  Comparison of the evolution of the score of the Insomnia Severity Index (7-item self-report questionnaire assessing the nature, severity, and impact of insomnia). Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The improvement will be defined as a decrease in the score of the questionnaire by 3 points between Day 90 and Day 0. A comparison of the improvement according to the 2 arms will be made.

  3 months

Secondary Outcomes (7)

• Evolution of sleep quality and sleep disorders

  3 months

• Evolution of drug consumption linked to chronic insomnia

  3 months

• Evolution and Anxiety and depression

  3 months

• Evolution of quality of life

  3 months

• Overall patient impression

  3 months

Study Arms (2)

Cryo-Auriculotherapy

EXPERIMENTAL

Patients benefit from 3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.

Device: Cryo-Auriculotherapy

Control group

SHAM COMPARATOR

Patients benefit from 3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.

Device: Sham comparator

Interventions

Cryo-Auriculotherapy DEVICE

3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.

Cryo-Auriculotherapy

Sham comparator DEVICE

3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.

Control group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (4)

Espace Santé Simone Veil

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

RECRUITING

Cabinet Médical Nouvelle France

Le Chesnay, Yvelines, 78158, France

ACTIVE NOT RECRUITING

Cabinet de l'Olivier

Montigny-le-Bretonneux, Yvelines, 78423, France

ACTIVE NOT RECRUITING

Hopital Foch

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mireille Michel-Cherqui, MD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireille Michel-Cherqui, MD

CONTACT

+33(0)146252985; m.michel-cherqui@hopital-foch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: July 15, 2020
• Study Start: October 14, 2020
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)