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

Study acronym: HypERR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Apr 14, 2027 → Oct 14, 2027
See other at-risk trials from Rennes University Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Apr 14, 2027 to Oct 14, 2027
    • Site contacts updated at 1 of 35 sites
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 33 to 35
    • Primary and study completion dates: Mar 15, 2027 to Apr 14, 2027
    • Start date changed from estimate of Sep 15, 2025 to Oct 14, 2025
    v3
  3. Minor Study sites: 34 to 33
    • Secondary endpoints revised (13)
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06898099
Lead Sponsor Rennes University Hospital
Collaborators: University of Rennes
Conditions
(from sponsor)
Chronic Insomnia
Related terms Sleep Initiation and Maintenance Disorders
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov