Non-pharmacological Treatments for Parasomnias
- Conditions
- NREM Parasomnia
- Interventions
- Other: Medical hypnosisOther: Standard Of Care
- Registration Number
- NCT05953207
- Lead Sponsor
- Chantal Berna Renella
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Medical hypnosis (HYP) Medical hypnosis 3 medical hypnosis interventions Standard Of Care (SOC) Standard Of Care 3 standard of care quality and sleep safety interventions
- Primary Outcome Measures
Name Time Method Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at 9 weeks) the treatment Parasomniac episodes scored on infrared home video recording
- Secondary Outcome Measures
Name Time Method Sleep airflow At Week 11 (optional) Using sleep airflow measures with Titanium, Embla®, NOX-A1®.
Incidence of emotions related to parasomniac episodes Through study duration, an average of 9 weeks 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?)
Anxiety and depression scores At Day 0 and Week 11 Using a standardized questionnaire: Hospital Anxiety and Depression Scale (HADS). Subscale score ranging from 3 to 21, score \>8 denotes anxiety or depression.
Sleep quality score At Week 2, Week 11 and Week 18 Using a standardized questionnaire: Pittsburgh Sleep Quality Index (PSQI). Score ranging from 0 to 21, higher score denoting greater acute sleep disturbances.
Duration of parasomniac episodes Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) treatment Using home video recording
Quality of life score At Day 0, Week 11 and Week 18 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.
Changes in imagery processes At Day 0 and Week 11 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®.
Sleepiness score At Week 2, Week 11 and Week 18 Using a standardized questionnaire: Epworth Sleepiness Scale (ESS). Score ranging from 0 to 24, higher score denoting higher daytime sleepiness.
Severity of arousal disorders score At Week 2, Week 11 and Week 18 Using a standardized questionnaire: Paris Arousal Disorders Severity Scale (PADSS). Score ranging from 0 to 50, higher score denoting more severed disorders.
Circadian typology score At Week 2, Week 11 and Week 18 Using a standardized questionnaire: Horne \& Östberg questionnaire. Score ranging from 16 to 86, higher score denoting morningness and lower score eveningness.
Sleep eye movements At Week 11 (optional) Using power spectral sleep EOG analysis (left and right) with Titanium, Embla®, NOX-A1®.
Sleep oxygen saturation At Week 11 (optional) Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®.
Sleep respiratory efforts At Week 11 (optional) Using abdominal and thoracic respiratory efforts measures with Titanium, Embla®, NOX-A1®.
Rate of confusional arousals, sleepwalking and sleep terrors episodes Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) the treatment Categorization of parasomniac episodes' complexity (confusional arousals, sleepwalking, sleep terrors) using home video recording
Traumatic events score At Day 0 Using a standardized questionnaire: Life Event Checklist for DSM-5 (LEC-5). It does not yield a total score or a composite score.
Fatigue score At Week 2, Week 11 and Week 18 Using a standardized questionnaire: Pichot's fatigue scale. Score ranging from 0 to 32, score \>22 denotes excessive fatigue.
Snoring At Week 11 (optional) Using snoring measures with Titanium, Embla®, NOX-A1®.
Sleep muscles activity At Week 11 (optional) Using power spectral sleep EMG analysis (chin and anterior tibialis muscle) with Titanium, Embla®, NOX-A1®
Sleep cardiac activity At Week 11 (optional) Using power spectral sleep ECG analysis (P wave, QRS complex, QT interval, PR interval...) with Titanium, Embla®, NOX-A1®.
Trial Locations
- Locations (1)
Centre hospitalier universitaire vaudois (CHUV)
🇨🇭Lausanne, Vaud, Switzerland