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

NCT06898099 | Recruiting

• 2 other identifiers: 35RC22_8973_HypERR2024-A01366-41
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 35

Brief 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).

Conditions

Chronic Insomnia

Keywords

chronic insomnia; E2R hypnosis; emotion-focused therapy; primary care; general medicine

Outcome Measures

Primary Outcomes (1)

• Severity of Insomnia assessed by the Insomnia Severity Index (ISI)

  Insomnia Severity Index (ISI). The minimum score is 0 meaning No Insomnia, the maximum is 28 meaning Severe clinical insomnia

  6 months

Secondary Outcomes (13)

• Severity of Insomnia assessed by the Insomnia Severity Index (ISI)

  3 months

• Number of responders assessed by the Insomnia Severity index (ISI)

  3 months

• Number of responders assessed by the Insomnia Severity index (ISI)

  6 months

• Number of partial responders assessed by the Insomnia Severity index (ISI)

  3 months

• Number of partial responders assessed by the Insomnia Severity index (ISI)

  6 months

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Patients will receive the usual care offered by their GP, the investigator in the study (except hypnosis).

Other: "Standard care" control group (without hypnosis)

E2R hypnosis

EXPERIMENTAL

4 x 30-minute hypnotherapy sessions over 6 weeks by the hypnotherapist using the E2R method (with self-hypnosis)

Other: Experimental group: "E2R 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.

Standard care

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.

E2R hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead
• University of Rennes: collaborator

Study Sites (35)

Cabinet médical

Bain-de-Bretagne, France

RECRUITING

Cabinet médical de Plaisance

Bouaye, France

RECRUITING

Cabinet médical de Plaisance

Bouaye, France

RECRUITING

Cabinet médical de Breteil

Breteil, France

RECRUITING

Cabinet médical

Cesson-Sévigné, France

RECRUITING

Cabinet médical du Linon

Combourg, France

RECRUITING

Cabinet médical Sycamore

Contres, France

WITHDRAWN

Cabinet médical de Corps Nuds

Corps-Nuds, France

NOT YET RECRUITING

Cabinet médical des Embruns

Crac'h, France

RECRUITING

Pôle Santé Physiomast

Dol-de-Bretagne, France

RECRUITING

MSP de l'Esplanade

Guer, France

RECRUITING

Maison médicale

Iffendic, France

RECRUITING

Cabinet Médical Chantepie

Joué Les Tours, France

RECRUITING

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

Jugon-les-Lacs, France

RECRUITING

Maison médicale des Longrais

La Chapelle-des-Fougeretz, France

RECRUITING

Cabinet médical

La Chapelle-Saint-Ursin, France

RECRUITING

Cabinet médical du Lion d'Or

Nantes, France

RECRUITING

Maison médicale Laennec

Pleudihen-sur-Rance, France

RECRUITING

Maison De Santé De Ronsouze

Ploërmel, France

RECRUITING

Cabinet médical Les Petits Ponts

Pont-Saint-Martin, France

RECRUITING

Cabinet médical Les Petits Ponts

Pont-Saint-Martin, France

RECRUITING

Maison de Santé de Questembert

Questembert, France

RECRUITING

Cabinet médical Olec

Rennes, France

RECRUITING

Cabinet médical

Rennes, France

RECRUITING

Maison médicale pluridisciplinaire

Rouziers-de-Touraine, France

RECRUITING

Maison médical de Maen roch

Saint-Brice-en-Coglès, France

RECRUITING

Maison médicale

Saint-Gilles-Croix-de-Vie, France

RECRUITING

Maison médicale

Saint-Gilles-Croix-de-Vie, France

RECRUITING

Maison de soin du Couesnon

Saint-Ouen-des-Alleux, France

RECRUITING

Cabinet médical

Saint-Romain-sur-Cher, France

RECRUITING

Maison de santé

Sancerre, France

RECRUITING

Cabinet médical de la Blanchisserie

Sully-sur-Loire, France

RECRUITING

Maison de santé

Talensac, France

RECRUITING

Cabinet des médecins généralistes de TIGY

Tigy, France

RECRUITING

Cabinet médical

Vildé-Guingalan, 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

• Eric MENER, Ph D

  University of Rennes (Department of general practice)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie VEISLINGER

CONTACT

2 23 23 33 38; Aurelie.VEISLINGER@chu-rennes.fr

Isabelle LEROYER

CONTACT

299284321; isabelle.leroyer@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The HypERR study is a multicenter, randomized, open-label study designed to confirm the efficacy of a hypotherapy method called E2R in the management of chronic insomnia, by comparing it with standard care (without hypnosis)

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): April 14, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (35)