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

NCT ID: NCT06898099

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-03-15

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).

Detailed Description

The selection and inclusion of patients will be carried out by 34 GPs (General Practitioner), the study investigators. They will then randomize their patients into one of 2 groups: the E2R hypnosis group versus the "standard care" control group (without hypnosis).

Patients randomized to the hypnosis group will be referred by their GP to a hypnotherapist in their area within a 30-minute radius. They will receive 4 x 30-minute hypnotherapy sessions over 6 weeks.

For patients randomized to the control group, the GP will be free to implement psychotherapy and/or other non-medication interventions as usual (with the exception of hypnosis) and/or medication.

Then, all patients will be reviewed at 3 and 6 months by their GP (+/- 1 week) after randomization (D0) to assess the study criteria.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care

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

Group Type: ACTIVE_COMPARATOR

"Standard care" control group (without hypnosis)

Intervention Type: 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.

E2R hypnosis

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

Group Type: EXPERIMENTAL

Experimental group: "E2R hypnosis"

Intervention Type: 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.

Interventions

"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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University

UNKNOWN

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric MENER, Ph D

Role: PRINCIPAL_INVESTIGATOR

University of Rennes (Department of general practice)

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

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 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

Countries

France

Central Contacts

Aurélie VEISLINGER

Role: CONTACT

Aurelie.VEISLINGER@chu-rennes.fr

2 23 23 33 38 ext. +33

Isabelle LEROYER

Role: CONTACT

isabelle.leroyer@chu-rennes.fr

299284321 ext. +33

Facility Contacts

Elise RIDARD, MD

Role: primary

elise.ridard@univ-rennes.fr

2 99 43 86 87 ext. +33

Ségolène AIRIEAU, MD

Role: primary

segoleneairieau.pro@gmail.com

2 40 32 60 70 ext. +33

Marine CHAMPIGNEUX, MD

Role: primary

drchampigneux@gmail.com

2 40 32 60 70 ext. +33

François TANGUY, MD

Role: primary

francois-tanguy@orange.fr

2 99 61 59 26 ext. +33

Adeline PFORR, MD

Role: primary

adeline.pforr@gmail.com

9 99 05 23 23 ext. +33

Frédéric MAS, MD

Role: primary

frederic.mas@gmail.com

2 99 73 00 34 ext. +33

Fabien AZEVEDO, MD

Role: primary

fabien.azevedo@hotmail.fr

2 34 46 06 35 ext. +33

Mathilde NGUYEN, MD

Role: primary

nguyenm.mathilde@gmail.com

2 99 09 10 83 ext. +33

Isabelle EZANNO, MD

Role: primary

drisabelle.ezanno@gmail.com

9 73 51 86 79 ext. +33

Fabienne BENOIT-ROLLAND, MD

Role: primary

fab.rollandbenoit@gmail.com

2 99 88 45 45 ext. +33

Emilie JAMOIS, MD

Role: primary

jamois_emilie@hotmail.com

2 23 43 66 28 ext. +33

Sophie LIZE, MD

Role: primary

lize.sophie@yahoo.fr

2 47 73 70 00 ext. +33

Madeline LASSERRE, MD

Role: primary

madeline.lasserre@gmail.com

2 96 31 68 19 ext. +33

Marie LELIEVRE, MD

Role: primary

drlelievrem@gmail.com

9 99 69 87 07 ext. +33

Marie-Louise DUGUE, MD

Role: primary

maril070184@hotmail.fr

2 18 81 00 11 ext. +33

Elsa HAUTREUX, MD

Role: primary

elsahautreux@hotmail.fr

2 40 34 45 25 ext. +33

Nicolas GUILLERM, MD

Role: primary

guillerm.nicolas@gmail.com

2 96 83 20 25 ext. +33

Emilie RUSQUET, MD

Role: primary

emilie.rusquet@gmail.com

2 97 74 56 00 ext. +33

Elodie DUBUISSON, MD

Role: primary

drelodiedubuisson@gmail.com

2 49 10 34 39 ext. +33

Betty LE DAHERON, MD

Role: primary

drbettyledaheron@gmail.com

2 40 26 83 28 ext. +33

Marielle VINATIER, MD

Role: primary

marielle.vinatier@gmail.com

2 97 26 15 20 ext. +33

Pierre LE DOUARON, MD

Role: primary

pierre.ledouaron@univ-rennes.fr

2 22 91 12 30 ext. +33

Anne-Sophie LEJEAU, MD

Role: primary

docteur.lejeau@gmail.com

2 23 28 13 20 ext. +33

Anne-Claire DUFLOT, MD

Role: primary

duflot_ac@hotmail.com

2 99 98 69 41 ext. +33

Etienne JULIEN, MD

Role: primary

etiennejulien2020@gmail.com

2 51 55 11 93 ext. +33

Christine RABILLER, MD

Role: primary

christine.rabiller@wanadoo.fr

2 51 55 11 93 ext. +33

Pierre GUE, MD

Role: primary

pierre.gue@gmail.com

Mathilde GERY, MD

Role: primary

gery.mathilde@orange.fr

2 54 71 71 01 ext. +33

Florence LAUVERJAT, MD

Role: primary

flo_lauv@yahoo.fr

2 48 78 00 00 ext. +33

Philippe MALLET, MD

Role: primary

phmallet45@gmail.com

2 38 36 24 46 ext. +33

Lucie MURGALE, MD

Role: primary

dr.murgale@orange.fr

2 99 09 10 83 ext. +33

Patrick DEFREMONT, MD

Role: primary

dr.patrick.defremont@orange.fr

2 38 58 14 00 ext. +33

Ronan QUERIC, MD

Role: primary

ronan.queric.pro@outlook.fr

2 96 27 01 79 ext. +33

Other Identifiers

2024-A01366-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

35RC22_8973_HypERR

Identifier Type: -

Identifier Source: org_study_id