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

Sponsor: Rennes University Hospital • ClinicalTrials.gov ID: NCT06898099

Registry updated: 2026-08-19

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Description

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).

Interventions

"Standard care" control group (without hypnosis) (Other)
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.
Experimental group: "E2R hypnosis" (Other)
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.

Eligibility criteria

Inclusion Criteria: * Patient aged 18 or over, * Patient suffering from chronic insomnia according to the DSM-5 definition, whether or not treated with psychotropic drugs: \* At least one of the following sleep disorders: difficulty in falling asleep, difficulty in maintaining sleep, waking up too early and inability to go back to sleep, and \* At least 3 nights a week for at least 3 months, and \* In an adequate night-time sleep context, and \* With at least one significant impact on, or impairment of, social, occupational or behavioral functioning, and \* Insomnia not attributable to the physiological effects of a substance, and \* Insomnia not explicable by a medical condition or mental disorder. * Patient willing to undergo hypnotherapy for 4 sessions of 30 min over 6 weeks, * Patient whose treating physician is the investigator, * Patient able to give free, informed, written consent, * Patient affiliated to the French social security system. Exclusion Criteria: * Patients receiving or having received one or more hypnotherapy sessions (for any reason) in the last 5 years prior to inclusion, * Patient participating in another study involving the treatment of insomnia or another pathology having an impact on sleep disorders, * Patient unable to complete a self-administered questionnaire, * Patients with poor or no understanding of the French language, * Patients unable to attend hypnotherapy consultations, * Deaf or hard-of-hearing patients without hearing aids, * Patient under legal protection (safeguard of justice, curatorship, guardianship) or deprived of liberty, * Women declaring themselves pregnant or breastfeeding.

Conditions

Chronic Insomnia

Locations

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

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