An interventional study of "Standard care" control group (without hypnosis) and Experimental group: "E2R hypnosis" in Chronic Insomnia, sponsored by Rennes University Hospital. Recruiting at 35 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Treatment
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).
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.
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This study's planned enrollment of 136 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Patient suffering from chronic insomnia according to the 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive the usual care offered by their GP, the investigator in the study (except hypnosis).
Other: "Standard care" control group (without 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. 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.
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.
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
Time frame: 6 months
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 6 months
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Plan to share: 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
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