Paraszomniák nem gyógyszeres kezelése (Hypnosomnia)
A parasomniák nem gyógyszeres kezelései hatékonyságának értékelése: randomizált, kontrollált vizsgálat
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 (N=60).
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 (EEG). 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 EEG 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.
For the validation of the EEG methodology, healthy volunteers (N=50) will complete a unique visit resembling the initial study visit of patients.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Canton of Vaud
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Lausanne, Canton of Vaud, Svájc, 1005
- Centre hospitalier universitaire vaudois (CHUV)
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Patients with NREM parasomnia (N=60):
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)
Healthy volunteers (N=50):
Inclusion Criteria:
- Adult (≥ 18 yo) willing and able to give informed consent.
Exclusion criteria:
- Presence of NREM parasomnias diagnosis, or any other concomitant sleep disorder;
- Current intake 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 psychiatric disorder (e.g., severe depressive or anxiety disorder or psychotic disorder);
- Current history of psychiatric or neurological disorders (e.g., migraines).
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Medical hypnosis (HYP) (N=30)
3 medical hypnosis interventions |
Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation) |
|
Aktív összehasonlító: Standard Of Care (SOC) (N=30)
3 standard of care quality and sleep safety interventions |
Sleep hygiene and safety education session |
|
Nincs beavatkozás: Healthy volunteers (N=50)
Unique EEG visit resembling the initial study visit of patients with NREM parasomnias |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
Időkeret: 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 |
Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at 9 weeks) the treatment
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Duration of parasomniac episodes
Időkeret: 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 |
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
Időkeret: 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 |
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
Időkeret: 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?) |
Through study duration, an average of 9 weeks
|
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Quality of life score
Időkeret: At Day 0, Week 11 and Week 18
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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
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|
Anxiety and depression scores
Időkeret: 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. |
At Day 0 and Week 11
|
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Traumatic events score
Időkeret: At Day 0
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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
|
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Fatigue score
Időkeret: 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. |
At Week 2, Week 11 and Week 18
|
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Sleepiness score
Időkeret: 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. |
At Week 2, Week 11 and Week 18
|
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Sleep quality score
Időkeret: At Week 2, Week 11 and Week 18
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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
|
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Severity of arousal disorders score
Időkeret: At Week 2, Week 11 and Week 18
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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
Időkeret: At Week 2, Week 11 and Week 18
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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
|
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Changes in sleep architecture
Időkeret: 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®. |
At Day 0 and Week 11
|
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Sleep eye movements
Időkeret: At Week 11 (optional)
|
Using power spectral sleep EOG analysis (left and right) with Titanium, Embla®, NOX-A1®. |
At Week 11 (optional)
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Sleep muscles activity
Időkeret: At Week 11 (optional)
|
Using power spectral sleep EMG analysis (chin and anterior tibialis muscle) with Titanium, Embla®, NOX-A1® |
At Week 11 (optional)
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Sleep cardiac activity
Időkeret: At Week 11 (optional)
|
Using power spectral sleep ECG analysis (P wave, QRS complex, QT interval, PR interval...) with Titanium, Embla®, NOX-A1®. |
At Week 11 (optional)
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Sleep oxygen saturation
Időkeret: At Week 11 (optional)
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Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®. |
At Week 11 (optional)
|
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Sleep airflow
Időkeret: At Week 11 (optional)
|
Using sleep airflow measures with Titanium, Embla®, NOX-A1®. |
At Week 11 (optional)
|
|
Sleep respiratory efforts
Időkeret: At Week 11 (optional)
|
Using abdominal and thoracic respiratory efforts measures with Titanium, Embla®, NOX-A1®. |
At Week 11 (optional)
|
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Snoring
Időkeret: At Week 11 (optional)
|
Using snoring measures with Titanium, Embla®, NOX-A1®. |
At Week 11 (optional)
|
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Changes in imagery processes
Időkeret: At Day 0 and Week 11 for patients.
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Using patients' EEG measures (N=60) collected with a 124-channel waveguardTMoriginal EEG cap and during 3-minute pleasant imagery suggestion audio recordings. |
At Day 0 and Week 11 for patients.
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Validation of the EEG methodology for the imagery processes recordings
Időkeret: At Day 0
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Using healthy volunteers' EEG measures (N=50) collected with a 124-channel waveguardTMoriginal EEG and during 5-minute pleasant imagery suggestion audio recordings. |
At Day 0
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Chantal Berna Renella, Prof, CHUV
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CER-VD 2023-01007
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