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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Other: "Standard care" control group (without hypnosis); Other: Experimental group: "E2R 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.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle LEROYER; Phone Number: +33 299284321; Email: isabelle.leroyer@chu-rennes.fr
• Study Contact Backup: Name: Aurélie VEISLINGER; Phone Number: +33 2 23 23 33 38; Email: Aurelie.VEISLINGER@chu-rennes.fr

Study Locations

• France
  • Bain-de-Bretagne, France
    • Recruiting
    • Cabinet Medical
    • Contact: Elise RIDARD, MD; Phone Number: +33 2 99 43 86 87; Email: elise.ridard@univ-rennes.fr
    • Principal Investigator: RIDARD
  • Bouaye, France
    • Recruiting
    • Cabinet médical de Plaisance
    • Contact: Marine CHAMPIGNEUX, MD; Phone Number: +33 2 40 32 60 70; Email: drchampigneux@gmail.com
    • Principal Investigator: CHAMPIGNEUX
  • Breteil, France
    • Recruiting
    • Cabinet médical de Breteil
    • Contact: François TANGUY, MD; Phone Number: +33 2 99 61 59 26; Email: francois-tanguy@orange.fr
    • Principal Investigator: TANGUY
  • Cesson-Sévigné, France
    • Recruiting
    • Cabinet Medical
    • Contact: Adeline PFORR, MD; Phone Number: +33 9 99 05 23 23; Email: adeline.pforr@gmail.com
    • Principal Investigator: PFORR
  • Combourg, France
    • Recruiting
    • Cabinet médical du Linon
    • Contact: Frédéric MAS, MD; Phone Number: +33 2 99 73 00 34; Email: frederic.mas@gmail.com
    • Principal Investigator: MAS
  • Contres, France
    • Withdrawn
    • Cabinet médical Sycamore
  • Corps-Nuds, France
    • Not yet recruiting
    • Cabinet médical de Corps Nuds
    • Principal Investigator: NGUYEN
    • Contact: Mathilde NGUYEN, MD; Phone Number: +33 2 99 09 10 83; Email: nguyenm.mathilde@gmail.com
  • Crac'h, France
    • Recruiting
    • Cabinet médical des Embruns
    • Contact: Isabelle EZANNO, MD; Phone Number: +33 9 73 51 86 79; Email: drisabelle.ezanno@gmail.com
    • Principal Investigator: EZANNO
  • Dol-de-Bretagne, France
    • Recruiting
    • Pôle Santé Physiomast
    • Contact: Fabienne BENOIT-ROLLAND, MD; Phone Number: +33 2 99 88 45 45; Email: fab.rollandbenoit@gmail.com
    • Principal Investigator: BENOIT-ROLLAND
  • Guer, France
    • Recruiting
    • MSP de l'Esplanade
    • Contact: Sandra LE FLOCH, MD; Email: dr.sandralefloch@yahoo.fr
    • Principal Investigator: Sandra LE FLOCH, MD
  • Iffendic, France
    • Recruiting
    • Maison médicale
    • Contact: Emilie JAMOIS, MD; Phone Number: +33 2 23 43 66 28; Email: jamois_emilie@hotmail.com
    • Principal Investigator: JAMOIS
  • Joué Les Tours, France
    • Recruiting
    • Cabinet Médical Chantepie
    • Contact: Sophie LIZE, MD; Phone Number: +33 2 47 73 70 00; Email: lize.sophie@yahoo.fr
    • Principal Investigator: LIZE
  • Jugon-les-Lacs, France
    • Recruiting
    • Cabinet Médical de Jugon-Les-Lacs -Saint-Igneuc
    • Contact: Madeline LASSERRE, MD; Phone Number: +33 2 96 31 68 19; Email: madeline.lasserre@gmail.com
    • Principal Investigator: LASSERRE
  • La Chapelle-Saint-Ursin, France
    • Recruiting
    • Cabinet Medical
    • Contact: Marie-Louise DUGUE, MD; Phone Number: +33 2 18 81 00 11; Email: maril070184@hotmail.fr
    • Principal Investigator: DUGUE
  • La Chapelle-des-Fougeretz, France
    • Recruiting
    • Maison médicale des Longrais
    • Contact: Marie LELIEVRE, MD; Phone Number: +33 9 99 69 87 07; Email: drlelievrem@gmail.com
    • Principal Investigator: LELIEVRE
  • Nantes, France
    • Recruiting
    • Cabinet médical du Lion d'Or
    • Contact: Elsa HAUTREUX, MD; Phone Number: +33 2 40 34 45 25; Email: elsahautreux@hotmail.fr
    • Principal Investigator: HAUTREUX
  • Pleudihen-sur-Rance, France
    • Recruiting
    • Maison médicale Laennec
    • Contact: Nicolas GUILLERM, MD; Phone Number: +33 2 96 83 20 25; Email: guillerm.nicolas@gmail.com
    • Principal Investigator: GUILLERM
  • Ploërmel, France
    • Recruiting
    • Maison De Santé De Ronsouze
    • Contact: Emilie RUSQUET, MD; Phone Number: +33 2 97 74 56 00; Email: emilie.rusquet@gmail.com
    • Principal Investigator: RUSQUET
  • Pont-Saint-Martin, France
    • Recruiting
    • Cabinet médical Les Petits Ponts
    • Contact: Betty LE DAHERON, MD; Phone Number: +33 2 40 26 83 28; Email: drbettyledaheron@gmail.com
    • Principal Investigator: LE DAHERON
  • Questembert, France
    • Recruiting
    • Maison de Santé de Questembert
    • Contact: Marielle VINATIER, MD; Phone Number: +33 2 97 26 15 20; Email: marielle.vinatier@gmail.com
    • Principal Investigator: VINATIER
  • Rennes, France
    • Recruiting
    • Cabinet médical Olec
    • Contact: Pierre LE DOUARON, MD; Phone Number: +33 2 22 91 12 30; Email: pierre.ledouaron@univ-rennes.fr
    • Principal Investigator: LE DOUARON
  • Rennes, France
    • Recruiting
    • Cabinet Medical
    • Contact: Anne-Sophie LEJEAU, MD; Phone Number: +33 2 23 28 13 20; Email: docteur.lejeau@gmail.com
    • Principal Investigator: LEJEAU
  • Rouziers-de-Touraine, France
    • Recruiting
    • Maison médicale pluridisciplinaire
    • Contact: Flora LEAUTE; Phone Number: 9 70 52 03 72; Email: docteur.flora.leaute@gmail.com
    • Principal Investigator: Flora LEAUTE, MD
  • Saint-Brice-en-Coglès, France
    • Recruiting
    • Maison médical de Maen roch
    • Contact: Anne-Claire DUFLOT, MD; Phone Number: +33 2 99 98 69 41; Email: duflot_ac@hotmail.com
    • Principal Investigator: DUFLOT
  • Saint-Gilles-Croix-de-Vie, France
    • Recruiting
    • Maison médicale
    • Contact: Christine RABILLER, MD; Phone Number: +33 2 51 55 11 93; Email: christine.rabiller@wanadoo.fr
    • Principal Investigator: RABILLER
  • Saint-Ouen-des-Alleux, France
    • Recruiting
    • Maison de soin du Couesnon
    • Contact: Pierre GUE, MD; Email: pierre.gue@gmail.com
    • Principal Investigator: GUE
  • Saint-Romain-sur-Cher, France
    • Recruiting
    • Cabinet Medical
    • Contact: Mathilde GERY, MD; Phone Number: +33 2 54 71 71 01; Email: gery.mathilde@orange.fr
    • Principal Investigator: GERY
  • Sancerre, France
    • Recruiting
    • Maison de santé
    • Contact: Florence LAUVERJAT, MD; Phone Number: +33 2 48 78 00 00; Email: flo_lauv@yahoo.fr
    • Principal Investigator: LAUVERJAT
  • Sully-sur-Loire, France
    • Recruiting
    • Cabinet médical de la Blanchisserie
    • Contact: Philippe MALLET, MD; Phone Number: +33 2 38 36 24 46; Email: phmallet45@gmail.com
    • Principal Investigator: MALLET
  • Talensac, France
    • Recruiting
    • Maison de santé
    • Contact: Lucie MURGALE, MD; Phone Number: +33 2 99 09 10 83; Email: dr.murgale@orange.fr
    • Principal Investigator: MURGALE
  • Tigy, France
    • Recruiting
    • Cabinet des médecins généralistes de TIGY
    • Contact: Patrick DEFREMONT, MD; Phone Number: +33 2 38 58 14 00; Email: dr.patrick.defremont@orange.fr
    • Principal Investigator: DEFREMONT
  • Vildé-Guingalan, France
    • Recruiting
    • Cabinet Medical
    • Contact: Ronan QUERIC, MD; Phone Number: +33 2 96 27 01 79; Email: ronan.queric.pro@outlook.fr
    • Principal Investigator: QUERIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; Patients will receive the usual care offered by their GP, the investigator in the study (except hypnosis).	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.
Experimental: E2R hypnosis; 4 x 30-minute hypnotherapy sessions over 6 weeks by the hypnotherapist using the E2R method (with self-hypnosis)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
Number of responders assessed by the Insomnia Severity index (ISI)	The responders are defined by a decrease > 7 points on the ISI scale	3 months
Number of responders assessed by the Insomnia Severity index (ISI)	The responders are defined by a decrease > 7 points on the ISI scale	6 months
Number of partial responders assessed by the Insomnia Severity index (ISI)	Partial responders are defined by a decrease between 4 and 7 points on the ISI scale)	3 months
Number of partial responders assessed by the Insomnia Severity index (ISI)	Partial responders are defined by a decrease between 4 and 7 points on the ISI scale)	6 months
Number of non-responders assessed by the Insomnia Severity index (ISI)	Non-responders are defined by a decrease < 4 points on ISI scale	3 months
Number of non-responders assessed by the Insomnia Severity index (ISI)	Non-responders are defined by a decrease < 4 points on ISI scale	6 months
Consumption of Benzodiazepine and related drug assessed by the prescription and patient interview	Benzodiazepine and related drug consumption recorded by the investigator (prescription and patient interview).	3 months
Consumption of Benzodiazepine and related drug assessed by the prescription and patient interview	Benzodiazepine and related drug consumption recorded by the investigator (prescription and patient interview).	6 months
Sleep quality assessed by the Pittsburg Sleep Quality Index (PSQI)	Pittsburg Sleep Quality Index (PSQI self-questionnaire). The minimum score is 0 meaning no difficulty, the maximum score is 21 indicating major difficulties	3 months
Sleep quality assessed by the Pittsburg Sleep Quality Index (PSQI)	Pittsburg Sleep Quality Index (PSQI self-questionnaire). The minimum score is 0 meaning no difficulty, the maximum score is 21 indicating major difficulties	6 months
Incidence of neuropsychiatric Non-Serious Adverse Events (Safety) of E2R hypnosis method in primary care	Number and nature of neuropsychiatric Non-Serious Adverse Events (NSEs) that occurred or worsened during the study period.	6 months
Incidence of Serious Adverse Events (Safety) of E2R hypnosis method in primary care	Number and nature of Serious Adverse Events (EvIG) over the follow-up period	6 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: University of Rennes
• Investigators: Principal Investigator: Eric MENER, Ph D, University of Rennes (Department of general practice)

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): April 14, 2027

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: primary care; chronic insomnia; general medicine; E2R hypnosis; emotion-focused therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 35RC22_8973_HypERR; 2024-A01366-41 (Registry Identifier: ID-RCB_ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After informing patients, In accordance : data protection provisions (GDPR and French Data Protection Act) :

Intention to share individual data All individual data collected during the study, after pseudonymization and minimization Protocol, amendments, observation log, information sheet and research consent form, statistical analysis plan, statistical analysis code, statistical report, study report without personal data, list of tables, variables and their definitions Data availability : Immediately after publication of the main analysis results and until the database is deleted Data recipients: Project leaders whose reuse has been approved by the sponsor (owner of the study data) and by the study steering committee Types of analyses: Analyses enabling the objectives defined in the sharing agreement to be achieved, which will be drawn up at the time of sharing Access via data request form sent to the promoter and data sharing agreement signed before any data is made available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No