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Chronic InsomniaHypERRNCT06898099

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

A study testing Experimental group: "E2R hypnosis" in people with Chronic Insomnia, run by Rennes University Hospital at 35 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Insomnia
What is being tested?
Experimental group: "E2R hypnosis"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
35 sitesFrance
Study dates
14 Oct 2025to 14 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

35 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aurélie VEISLINGER contact

2 23 23 33 38 ext. +33

Aurelie.VEISLINGER@chu-rennes.fr

Isabelle LEROYER contact

299284321 ext. +33

isabelle.leroyer@chu-rennes.fr

35 sites in 1 country

France35 sites, 34 recruiting

  • Cabinet médical

    Bain-de-Bretagne

    Elise RIDARD, MD, 2 99 43 86 87 ext. +33, elise.ridard@univ-rennes.fr

    RIDARD

    Recruiting

  • Cabinet médical de Plaisance

    Bouaye

    Ségolène AIRIEAU, MD, 2 40 32 60 70 ext. +33, segoleneairieau.pro@gmail.com

    AIRIEAU

    Recruiting

  • Cabinet médical de Plaisance

    Bouaye

    Marine CHAMPIGNEUX, MD, 2 40 32 60 70 ext. +33, drchampigneux@gmail.com

    CHAMPIGNEUX

    Recruiting

  • Cabinet médical de Breteil

    Breteil

    François TANGUY, MD, 2 99 61 59 26 ext. +33, francois-tanguy@orange.fr

    TANGUY

    Recruiting

  • Cabinet médical

    Cesson-Sévigné

    Adeline PFORR, MD, 9 99 05 23 23 ext. +33, adeline.pforr@gmail.com

    PFORR

    Recruiting

  • Cabinet médical du Linon

    Combourg

    Frédéric MAS, MD, 2 99 73 00 34 ext. +33, frederic.mas@gmail.com

    MAS

    Recruiting

  • Cabinet médical Sycamore

    Contres

    Withdrawn

  • Cabinet médical de Corps Nuds

    Corps-Nuds

    Mathilde NGUYEN, MD, 2 99 09 10 83 ext. +33, nguyenm.mathilde@gmail.com

    NGUYEN

    Not yet recruiting

  • Cabinet médical des Embruns

    Crac'h

    Isabelle EZANNO, MD, 9 73 51 86 79 ext. +33, drisabelle.ezanno@gmail.com

    EZANNO

    Recruiting

  • Pôle Santé Physiomast

    Dol-de-Bretagne

    Fabienne BENOIT-ROLLAND, MD, 2 99 88 45 45 ext. +33, fab.rollandbenoit@gmail.com

    BENOIT-ROLLAND

    Recruiting

  • MSP de l'Esplanade

    Guer

    Sandra LE FLOCH, MD, dr.sandralefloch@yahoo.fr

    Sandra LE FLOCH, MD

    Recruiting

  • Maison médicale

    Iffendic

    Emilie JAMOIS, MD, 2 23 43 66 28 ext. +33, jamois_emilie@hotmail.com

    JAMOIS

    Recruiting

  • Cabinet Médical Chantepie

    Joué Les Tours

    Sophie LIZE, MD, 2 47 73 70 00 ext. +33, dr.lize.robidas@gmail.com

    LIZE

    Recruiting

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

    Jugon-les-Lacs

    Madeline LASSERRE, MD, 2 96 31 68 19 ext. +33, madeline.lasserre@gmail.com

    LASSERRE

    Recruiting

  • Maison médicale des Longrais

    La Chapelle-des-Fougeretz

    Marie LELIEVRE, MD, 9 99 69 87 07 ext. +33, drlelievrem@gmail.com

    LELIEVRE

    Recruiting

  • Cabinet médical

    La Chapelle-Saint-Ursin

    Marie-Louise DUGUE, MD, 2 18 81 00 11 ext. +33, maril070184@hotmail.fr

    DUGUE

    Recruiting

  • Cabinet médical du Lion d'Or

    Nantes

    Elsa HAUTREUX, MD, 2 40 34 45 25 ext. +33, elsahautreux@hotmail.fr

    HAUTREUX

    Recruiting

  • Maison médicale Laennec

    Pleudihen-sur-Rance

    Nicolas GUILLERM, MD, 2 96 83 20 25 ext. +33, guillerm.nicolas@gmail.com

    GUILLERM

    Recruiting

  • Maison De Santé De Ronsouze

    Ploërmel

    Emilie RUSQUET, MD, 2 97 74 56 00 ext. +33, emilie.rusquet@gmail.com

    RUSQUET

    Recruiting

  • Cabinet médical Les Petits Ponts

    Pont-Saint-Martin

    Elodie DUBUISSON, MD, 2 49 10 34 39 ext. +33, drelodiedubuisson@gmail.com

    DUBUISSON

    Recruiting

  • Cabinet médical Les Petits Ponts

    Pont-Saint-Martin

    Betty LE DAHERON, MD, 2 40 26 83 28 ext. +33, drbettyledaheron@gmail.com

    LE DAHERON

    Recruiting

  • Maison de Santé de Questembert

    Questembert

    Marielle VINATIER, MD, 2 97 26 15 20 ext. +33, marielle.vinatier@gmail.com

    VINATIER

    Recruiting

  • Cabinet médical Olec

    Rennes

    Pierre LE DOUARON, MD, 2 22 91 12 30 ext. +33, pierre.ledouaron@univ-rennes.fr

    LE DOUARON

    Recruiting

  • Cabinet médical

    Rennes

    Anne-Sophie LEJEAU, MD, 2 23 28 13 20 ext. +33, docteur.lejeau@gmail.com

    LEJEAU

    Recruiting

  • Maison médicale pluridisciplinaire

    Rouziers-de-Touraine

    Flora LEAUTE, 9 70 52 03 72, docteur.flora.leaute@gmail.com

    Flora LEAUTE, MD

    Recruiting

  • Maison médical de Maen roch

    Saint-Brice-en-Coglès

    Anne-Claire DUFLOT, MD, 2 99 98 69 41 ext. +33, duflot_ac@hotmail.com

    DUFLOT

    Recruiting

  • Maison médicale

    Saint-Gilles-Croix-de-Vie

    Etienne JULIEN, MD, 2 51 55 11 93 ext. +33, etiennejulien2020@gmail.com

    JULIEN

    Recruiting

  • Maison médicale

    Saint-Gilles-Croix-de-Vie

    Christine RABILLER, MD, 2 51 55 11 93 ext. +33, christine.rabiller@wanadoo.fr

    RABILLER

    Recruiting

  • Maison de soin du Couesnon

    Saint-Ouen-des-Alleux

    Pierre GUE, MD, pierre.gue@gmail.com

    GUE

    Recruiting

  • Cabinet médical

    Saint-Romain-sur-Cher

    Mathilde GERY, MD, 2 54 71 71 01 ext. +33, gery.mathilde@orange.fr

    GERY

    Recruiting

  • Maison de santé

    Sancerre

    Florence LAUVERJAT, MD, 2 48 78 00 00 ext. +33, flo_lauv@yahoo.fr

    LAUVERJAT

    Recruiting

  • Cabinet médical de la Blanchisserie

    Sully-sur-Loire

    Philippe MALLET, MD, 2 38 36 24 46 ext. +33, phmallet45@gmail.com

    MALLET

    Recruiting

  • Maison de santé

    Talensac

    Lucie MURGALE, MD, 2 99 09 10 83 ext. +33, dr.murgale@orange.fr

    MURGALE

    Recruiting

  • Cabinet des médecins généralistes de TIGY

    Tigy

    Patrick DEFREMONT, MD, 2 38 58 14 00 ext. +33, dr.patrick.defremont@orange.fr

    DEFREMONT

    Recruiting

  • Cabinet médical

    Vildé-Guingalan

    Ronan QUERIC, MD, 2 96 27 01 79 ext. +33, ronan.queric.pro@outlook.fr

    QUERIC

    Recruiting

Other trials in France

About this study

Official title: 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).

Read the 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.

Being tested
"Standard care" control group (without hypnosis), Experimental group: "E2R hypnosis"
Keywords
chronic insomnia, E2R hypnosis, emotion-focused therapy, primary care, general medicine
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "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.

Study groups in NCT06898099
Study groupRoleWhat they receive
Standard careActive comparatorPatients will receive the usual care offered by their GP, the investigator in the study (except hypnosis).
Receives: Other: "Standard care" control group (without hypnosis)
E2R hypnosisExperimental4 x 30-minute hypnotherapy sessions over 6 weeks by the hypnotherapist using the E2R method (with self-hypnosis)
Receives: Other: Experimental group: "E2R hypnosis"

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (13)

  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

    Measured: 3 months

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

    The responders are defined by a decrease > 7 points on the ISI scale

    Measured: 3 months

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

    The responders are defined by a decrease > 7 points on the ISI scale

    Measured: 6 months

  4. 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)

    Measured: 3 months

  5. 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)

    Measured: 6 months

  6. Number of non-responders assessed by the Insomnia Severity index (ISI)

    Non-responders are defined by a decrease < 4 points on ISI scale

    Measured: 3 months

  7. Number of non-responders assessed by the Insomnia Severity index (ISI)

    Non-responders are defined by a decrease < 4 points on ISI scale

    Measured: 6 months

  8. 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).

    Measured: 3 months

  9. 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).

    Measured: 6 months

  10. 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

    Measured: 3 months

  11. 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

    Measured: 6 months

  12. 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.

    Measured: 6 months

  13. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2025
  2. Study start14 Oct 2025
  3. Primary completion14 Oct 2027 (estimated)
  4. Study completion14 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06898099
Sponsor's protocol ID
35RC22_8973_HypERR
Other IDs
2024-A01366-41
Acronym
HypERR
Status last verified
Aug 2026
First submitted
20 Mar 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A study testing Experimental group: "E2R hypnosis" in people with Chronic Insomnia, run by Rennes University Hospital at 35 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurélie VEISLINGER (2 23 23 33 38 ext. +33, Aurelie.VEISLINGER@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of Insomnia assessed by the Insomnia Severity Index (ISI) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06898099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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