Non-pharmacological Treatments for Parasomnias

NREM Parasomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953207
• Other study ID #: CER-VD 2023-01007
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: Centre de Médecine Intégrative et Complémentaire (CEMIC)
• Contact: Geoffroy Solelhac, Dr.
• Phone: +41 79 556 34 48
• Email: geoffroy.solelhac[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• NREM Parasomnia
• Parasomnias
• Sleep Wake Disorders

Intervention

Other:
• Medical hypnosis
Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation)
• Standard Of Care
Sleep hygiene and safety education session

Locations

Country	Name	City	State
Switzerland	Centre hospitalier universitaire vaudois (CHUV)	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Chantal Berna Renella	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sleep eye movements	Using power spectral sleep EOG analysis (left and right) with Titanium, Embla®, NOX-A1®.	At Week 11 (optional)
Secondary	Sleep muscles activity	Using power spectral sleep EMG analysis (chin and anterior tibialis muscle) with Titanium, Embla®, NOX-A1®	At Week 11 (optional)
Secondary	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)
Secondary	Sleep oxygen saturation	Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®.	At Week 11 (optional)
Secondary	Sleep airflow	Using sleep airflow measures with Titanium, Embla®, NOX-A1®.	At Week 11 (optional)
Secondary	Sleep respiratory efforts	Using abdominal and thoracic respiratory efforts measures with Titanium, Embla®, NOX-A1®.	At Week 11 (optional)
Secondary	Snoring	Using snoring measures with Titanium, Embla®, NOX-A1®.	At Week 11 (optional)