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RECRUITING
NCT06898099
NA

Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)

Sponsor: Rennes University Hospital

View on ClinicalTrials.gov

Summary

In France, the treatment of chronic insomnia relies mainly on hypnotic drugs in routine care, despite the high level of iatrogenicity. Cognitive-behavioral therapy (CBT) is recommended by the HAS as a non-pharmaceutical first-line therapy for chronic insomnia. Despite evidence of their efficacy in chronic insomnia, these therapies remain underdeveloped in France (few practitioners, time-consuming for the patient). Hypnotherapy is another non-drug intervention suitable for routine outpatient care. Among the hypnosis methods practiced in France, E2R (Emotion, Regression, Repair) is a hypnotherapy method used in general practice, particularly for chronic insomnia. To date, no clinical trials have been carried out to demonstrate its effectiveness in this pathology. The HypERR study is a multicenter, randomized, open-label study designed to evaluate the efficacy of a hypotherapy method called E2R in the management of chronic insomnia, by comparing it with standard care (without hypnosis).

Official title: Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2025-10-14

Completion Date

2027-04-14

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

OTHER

"Standard care" control group (without hypnosis)

Randomization stratification on insomnia severity. In the "Standard care" group, the investigating physician will not change his or her current practice as part of the study. Treatment will be the same as usual, whether drug-based or not (psychotherapy, etc.), with the exception of hypnosis. The patients will be reviewed at 3 months and 6 months (+/- 1 week) after randomization (D0). The following study information and questionnaires will be completed according to patients' responses: ISI and PSQI self-questionnaires, Record of psychotropic medications, Record of any non-drug therapies implemented, Events that could modify sleep, Serious adverse events (EvIG) and non-serious adverse events (EvING) of a neuropsychiatric nature that occurred or worsened during the study.

OTHER

Experimental group: "E2R hypnosis"

Randomization stratification on insomnia severity. For the patients randomized to the Hypnosis E2R arm, patients summoned within 15 days to 3 weeks of inclusion for their first hypnotherapy session with the hypnotherapist. All patients will receive 4 hypnotherapy sessions over 6 weeks using the E2R method. The patients will be reviewed at 3 months and 6 months (+/- 1 week) after randomization (D0). The following study information and questionnaires will be completed according to patients' responses: ISI and PSQI self-questionnaires, Record of psychotropic medications, Record of any non-drug therapies implemented, Practice of self-hypnosis requested of the patient (patient diary), Events that could modify sleep, Serious adverse events (EvIG) and non-serious adverse events (EvING) of a neuropsychiatric nature that occurred or worsened during the study.

Locations (35)

Cabinet médical

Bain-de-Bretagne, France

Cabinet médical de Plaisance

Bouaye, France

Cabinet médical de Plaisance

Bouaye, France

Cabinet médical de Breteil

Breteil, France

Cabinet médical

Cesson-Sévigné, France

Cabinet médical du Linon

Combourg, France

Cabinet médical Sycamore

Contres, France

Cabinet médical de Corps Nuds

Corps-Nuds, France

Cabinet médical des Embruns

Crac'h, France

Pôle Santé Physiomast

Dol-de-Bretagne, France

MSP de l'Esplanade

Guer, France

Maison médicale

Iffendic, France

Cabinet Médical Chantepie

Joué Les Tours, France

Cabinet Médical de Jugon-Les-Lacs -Saint-Igneuc

Jugon-les-Lacs, France

Maison médicale des Longrais

La Chapelle-des-Fougeretz, France

Cabinet médical

La Chapelle-Saint-Ursin, France

Cabinet médical du Lion d'Or

Nantes, France

Maison médicale Laennec

Pleudihen-sur-Rance, France

Maison De Santé De Ronsouze

Ploërmel, France

Cabinet médical Les Petits Ponts

Pont-Saint-Martin, France

Cabinet médical Les Petits Ponts

Pont-Saint-Martin, France

Maison de Santé de Questembert

Questembert, France

Cabinet médical Olec

Rennes, France

Cabinet médical

Rennes, France

Maison médicale pluridisciplinaire

Rouziers-de-Touraine, France

Maison médical de Maen roch

Saint-Brice-en-Coglès, France

Maison médicale

Saint-Gilles-Croix-de-Vie, France

Maison médicale

Saint-Gilles-Croix-de-Vie, France

Maison de soin du Couesnon

Saint-Ouen-des-Alleux, France

Cabinet médical

Saint-Romain-sur-Cher, France

Maison de santé

Sancerre, France

Cabinet médical de la Blanchisserie

Sully-sur-Loire, France

Maison de santé

Talensac, France

Cabinet des médecins généralistes de TIGY

Tigy, France

Cabinet médical

Vildé-Guingalan, France