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Non-pharmacological Treatments for Parasomnias

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

Inclusion Criteria:

  • Non-REM parasomnias diagnosis according to the international classification disease of sleep 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 Criteria:

  • Refusal to use the home video recording device
  • Current or planned intake (during the next 2 months) of medications/substances that may 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 sleep behaviour disorder, restless legs syndrome with symptoms more than 2 days/week)
  • A comorbid psychiatric disorder (e.g., severe depressive or anxiety disorder or psychotic disorder)

Study details

NREM Parasomnia

NCT05953207

Chantal Berna Renella

25 January 2024

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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