Non-pharmacological Treatments for Parasomnias

Chantal Berna Renella

Status: Enrolling

Conditions: NREM Parasomnia

Treatments: Other: Medical hypnosis; Other: Standard Of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05953207

CER-VD 2023-01007

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Medical hypnosis (HYP)

Experimental group

Description:

3 medical hypnosis interventions

Treatment:

Other: Medical hypnosis

Standard Of Care (SOC)

Active Comparator group

Description:

3 standard of care quality and sleep safety interventions

Treatment:

Other: Standard Of Care