Non-pharmacological Treatments for Parasomnias

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

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.

Study Overview

• Status: Recruiting
• Conditions: NREM Parasomnia
• Intervention / Treatment: Other: Medical hypnosis; Other: Standard Of Care

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geoffroy Solelhac, Dr.; Phone Number: +41 79 556 34 48; Email: geoffroy.solelhac@chuv.ch
• Study Contact Backup: Name: Nina Rimorini, MSc; Phone Number: +41 79 556 96 11; Email: nina.rimorini@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1005
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Contact: Nina Rimorini, MSc; Phone Number: +41 79 556 96 11; Email: nina.rimorini@chuv.ch
      • Contact: Geoffroy Solelhac, MD; Phone Number: +41 21 314 67 48; Email: geoffroy.solelhac@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chantal Berna Renella
• Collaborators: University of Lausanne Hospitals
• Investigators: Principal Investigator: Chantal Berna Renella, Prof, CHUV

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Medical hypnosis
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: CER-VD 2023-01007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No