Non-pharmacological Treatments for Parasomnias
NCT05953207 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-10-02
Summary
The goal of this clinical trial is to compare the efficacy of non-pharmacological treatments (medical hypnosis and standard treatment) in patients with a non-REM parasomnia diagnosis.
Participants are randomly assigned to one of the two treatments. Treatment consists of 3 sessions. Participants receiving the standard treatment (i.e., sleep hygiene and episode risk reduction) may subsequently receive medical hypnosis.
Participation in the study involves 5 visits in total: 3 treatment visits and 2 study visits to the hospital (CHUV).
* An initial study visit to provide information and collect questionnaires prior to the start of treatment. An initial non-therapeutic hypnosis session will be carried out during electroencephalography. Estimated duration: 2h.
* A second study visit at the end of treatment, including questionnaires about your sleep and treatment. A shorter non-therapeutic hypnosis session and a second electroencephalography will be performed. Estimated duration: 1h30. This visit may also be followed by an overnight polysomnography, according to patient's choice (if performed, estimated total duration 12 hrs).
This study also involves monitoring patients' sleep for 10 nights before and after treatment: they will fill in a sleep diary and use an infrared camera.
Conditions
- NREM Parasomnia
Interventions
- OTHER
-
Medical hypnosis
Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation)
- OTHER
-
Standard Of Care
Sleep hygiene and safety education session
Sponsors & Collaborators
-
University of Lausanne Hospitals
collaborator OTHER -
Chantal Berna Renella
lead OTHER
Principal Investigators
-
Chantal Berna Renella, Prof · CHUV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-30
- Primary Completion
- 2025-08-31
- Completion
- 2025-08-31
Countries
- Switzerland
Study Locations
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