NREM Parasomnia
Conditions
Keywords
Medical hypnosis
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 (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.
Interventions
OTHERMedical hypnosis
Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation)
OTHERStandard Of Care
Sleep hygiene and safety education session
Sponsors
Chantal Berna Renella
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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?) |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Changes in sleep architecture | 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®. |
| Sleep eye movements | At Week 11 (optional) | Using power spectral sleep EOG analysis (left and right) 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®. |
| Sleep oxygen saturation | At Week 11 (optional) | Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®. |
| Sleep airflow | At Week 11 (optional) | Using sleep airflow 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®. |
| Snoring | At Week 11 (optional) | Using snoring measures with Titanium, Embla®, NOX-A1®. |
| Changes in imagery processes | At Day 0 and Week 11 for patients. | Using patients' EEG measures (N=60) collected with a 124-channel waveguardTMoriginal EEG cap and during 3-minute pleasant imagery suggestion audio recordings. |
| Validation of the EEG methodology for the imagery processes recordings | At Day 0 | Using healthy volunteers' EEG measures (N=50) collected with a 124-channel waveguardTMoriginal EEG and during 5-minute pleasant imagery suggestion audio recordings. |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORChantal Berna Renella, Prof
CHUV
Outcome results
None listed