Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)
Launched by RENNES UNIVERSITY HOSPITAL · Mar 20, 2025
Trial Information
Current as of April 29, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The HypERR trial is studying a type of treatment called E2R hypnotherapy to see if it can help people with chronic insomnia. Chronic insomnia means having trouble sleeping, like having difficulty falling asleep or waking up too early, for at least three nights a week for three months. This study will compare the effects of E2R hypnotherapy to standard care, which usually involves medication. The goal is to find out if hypnotherapy can be an effective non-drug option for managing insomnia.
To be eligible for this study, participants need to be at least 18 years old and have chronic insomnia as defined by specific sleep difficulties. They should be willing to attend four hypnotherapy sessions over six weeks and be able to give their consent. The study is looking for people who are not currently receiving hypnotherapy, are not taking part in other insomnia studies, and understand French well enough to complete questionnaires. If you or a loved one fits these criteria, participating in this study could be a way to explore a new approach to managing sleep problems.
Gender
ALL
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.
About Rennes University Hospital
Rennes University Hospital, a leading academic medical center in France, is dedicated to advancing healthcare through innovative clinical research and trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific research with clinical practice, fostering collaboration among multidisciplinary teams. Its commitment to excellence is reflected in its robust infrastructure and expertise in various medical fields, enabling the development and evaluation of novel therapies and treatment protocols. By participating in clinical trials, Rennes University Hospital aims to enhance patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bain De Bretagne, , France
Bouaye, , France
Bouaye, , France
Breteil, , France
Cesson Sévigné, , France
Combourg, , France
Contres, , France
Corps Nuds, , France
Crac'h, , France
Dol De Bretagne, , France
Guer, , France
Iffendic, , France
Joué Les Tours, , France
Jugon Les Lacs, , France
La Chapelle Saint Ursin, , France
La Chapelle Des Fougeretz, , France
Nantes, , France
Pleudihen Sur Rance, , France
Ploërmel, , France
Pont St Martin, , France
Pont St Martin, , France
Questembert, , France
Rennes, , France
Rennes, , France
Saint Brice En Coglès, , France
Saint Ouen Des Alleux, , France
Saint Romain Sur Cher, , France
Saint Gilles Croix De Vie, , France
Saint Gilles Croix De Vie, , France
Sancerre, , France
Sully Sur Loire, , France
Talensac, , France
Tigy, , France
Vildé Guingalan, , France
Patients applied
Trial Officials
Eric MENER, Ph D
Principal Investigator
University of Rennes (Department of general practice)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported