Status:
NOT_YET_RECRUITING
Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Rennes University
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 gr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06898099
Start Date
September 15 2025
End Date
March 15 2027
Last Update
July 29 2025
Active Locations (33)
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1
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Bain-de-Bretagne, France
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