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| Name | Class |
|---|---|
| University of Lausanne Hospitals | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical hypnosis (HYP) | Experimental | 3 medical hypnosis interventions |
|
| Standard Of Care (SOC) | Active Comparator | 3 standard of care quality and sleep safety interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical hypnosis | Other | Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geoffroy Solelhac, Dr. | Contact | +41 79 556 34 48 | geoffroy.solelhac@chuv.ch | |
| Nina Rimorini, Msc | Contact | +41 79 556 96 11 | nina.rimorini@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Chantal Berna Renella, Prof | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier universitaire vaudois (CHUV) | Recruiting | Lausanne | Canton of Vaud | 1005 | Switzerland |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Of Care | Other | Sleep hygiene and safety education session |
|
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) |