Non-pharmacological Treatments for Parasomnias

Last updated: September 28, 2023
Sponsor: Chantal Berna Renella
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Treatment

Standard Of Care

Medical hypnosis

Clinical Study ID

NCT05953207
CER-VD 2023-01007
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non-REM parasomnias diagnosis according to the international classification disease ofsleep disorders
  • Willling and able to give informed consent
  • Reporting at least one parasomniac episode per month
  • Reporting at least one parasomniac episode the month prior

Exclusion

Exclusion Criteria:

  • Refusal to use the home video recording device
  • Current or planned intake (during the next 2 months) of medications/substances thatmay interfere with sleep architecture (e.g., hypnotics, neuroleptics, antidepressants,benzodiazepines)
  • A comorbid significant somatic disease altering the brain (e.g., cancer, epilepsy,multiple sclerosis, dementia)
  • A comorbid sleep disorder (e.g., apnea-hypopnea index (AHI) >= 20/hour, REM sleepbehaviour disorder, restless legs syndrome with symptoms more than 2 days/week)
  • A comorbid psychiatric disorder (e.g., severe depressive or anxiety disorder orpsychotic disorder)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Standard Of Care
Phase:
Study Start date:
August 30, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Centre hospitalier universitaire vaudois (CHUV)

    Lausanne, Vaud 1005
    Switzerland

    Active - Recruiting

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