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ACTIVE NOT RECRUITING
NCT05953207
NA

Non-pharmacological Treatments for Parasomnias

Sponsor: Chantal Berna Renella

View on ClinicalTrials.gov

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 (N=60). 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 (EEG). 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 EEG 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. For the validation of the EEG methodology, healthy volunteers (N=50) will complete a unique visit resembling the initial study visit of patients.

Official title: Evaluation of the Efficacy of Non-pharmacological Treatments for Parasomnias: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2023-08-30

Completion Date

2026-08-15

Last Updated

2026-07-14

Healthy Volunteers

Yes

Conditions

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

Locations (1)

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland