Non-pharmacological Treatments for Parasomnias

Study Overview
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Brief Summary
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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.

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

Conditions
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NREM Parasomnia

Intervention / Treatment
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* Other: Medical hypnosis
* Other: Standard Of Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical hypnosis (HYP)<br>3 medical hypnosis interventions | Other: Medical hypnosis<br>* Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation)<br>|
| Active Comparator: Standard Of Care (SOC)<br>3 standard of care quality and sleep safety interventions | Other: Standard Of Care<br>* Sleep hygiene and safety education session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks | Parasomniac episodes scored on infrared home video recording | Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at 9 weeks) the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of parasomniac episodes | Using home video recording | Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) treatment | 
| Rate of confusional arousals, sleepwalking and sleep terrors episodes | Categorization of parasomniac episodes' complexity (confusional arousals, sleepwalking, sleep terrors) using home video recording | Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) the treatment | 
| Incidence of emotions related to parasomniac episodes | Emotional impact of parasomniac episodes using questionnaires (e.g., What emotions did you feel during these episodes?; Do you have negative emotions related to your parasomnias?) | Through study duration, an average of 9 weeks | 
| Quality of life score | Using a standardized questionnaire: World Health Organization Quality Of Life-BREF (WHOQOL-BREF). Score ranging from 0 to 100, higher score denoting greater perceived quality of life. | At Day 0, Week 11 and Week 18 | 
| Anxiety and depression scores | Using a standardized questionnaire: Hospital Anxiety and Depression Scale (HADS). Subscale score ranging from 3 to 21, score >8 denotes anxiety or depression. | At Day 0 and Week 11 | 
| Traumatic events score | Using a standardized questionnaire: Life Event Checklist for DSM-5 (LEC-5). It does not yield a total score or a composite score. | At Day 0 | 
| Fatigue score | Using a standardized questionnaire: Pichot's fatigue scale. Score ranging from 0 to 32, score >22 denotes excessive fatigue. | At Week 2, Week 11 and Week 18 | 
| Sleepiness score | Using a standardized questionnaire: Epworth Sleepiness Scale (ESS). Score ranging from 0 to 24, higher score denoting higher daytime sleepiness. | At Week 2, Week 11 and Week 18 | 
| Sleep quality score | Using a standardized questionnaire: Pittsburgh Sleep Quality Index (PSQI). Score ranging from 0 to 21, higher score denoting greater acute sleep disturbances. | At Week 2, Week 11 and Week 18 | 
| Severity of arousal disorders score | Using a standardized questionnaire: Paris Arousal Disorders Severity Scale (PADSS). Score ranging from 0 to 50, higher score denoting more severed disorders. | At Week 2, Week 11 and Week 18 | 
| Circadian typology score | Using a standardized questionnaire: Horne & Östberg questionnaire. Score ranging from 16 to 86, higher score denoting morningness and lower score eveningness. | At Week 2, Week 11 and Week 18 | 
| Changes in imagery processes | Using power spectral sleep EEG analysis including delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), sigma (12-16 Hz), and beta (18-30 Hz) frequency bands with Titanium, Embla®, NOX-A1®. | At Day 0 and Week 11 | 
| Sleep eye movements | Using power spectral sleep EOG analysis (left and right) with Titanium, Embla®, NOX-A1®. | At Week 11 (optional) | 
| Sleep muscles activity | Using power spectral sleep EMG analysis (chin and anterior tibialis muscle) with Titanium, Embla®, NOX-A1® | At Week 11 (optional) | 
| Sleep cardiac activity | Using power spectral sleep ECG analysis (P wave, QRS complex, QT interval, PR interval...) with Titanium, Embla®, NOX-A1®. | At Week 11 (optional) | 
| Sleep oxygen saturation | Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®. | At Week 11 (optional) | 
| Sleep airflow | Using sleep airflow measures with Titanium, Embla®, NOX-A1®. | At Week 11 (optional) | 
| Sleep respiratory efforts | Using abdominal and thoracic respiratory efforts measures with Titanium, Embla®, NOX-A1®. | At Week 11 (optional) | 
| Snoring | Using snoring measures with Titanium, Embla®, NOX-A1®. | At Week 11 (optional) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical hypnosis