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Non-pharmacological Treatments for Parasomnias

Primary Purpose

NREM Parasomnia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Medical hypnosis
Standard Of Care
Sponsored by
Chantal Berna Renella
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NREM Parasomnia focused on measuring Medical hypnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre hospitalier universitaire vaudois (CHUV)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medical hypnosis (HYP)

Standard Of Care (SOC)

Arm Description

3 medical hypnosis interventions

3 standard of care quality and sleep safety interventions

Outcomes

Primary Outcome Measures

Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
Parasomniac episodes scored on infrared home video recording

Secondary Outcome Measures

Duration of parasomniac episodes
Using home video recording
Rate of confusional arousals, sleepwalking and sleep terrors episodes
Categorization of parasomniac episodes' complexity (confusional arousals, sleepwalking, sleep terrors) using home video recording
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?)
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.
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.
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.
Fatigue score
Using a standardized questionnaire: Pichot's fatigue scale. Score ranging from 0 to 32, score >22 denotes excessive fatigue.
Sleepiness score
Using a standardized questionnaire: Epworth Sleepiness Scale (ESS). Score ranging from 0 to 24, higher score denoting higher daytime sleepiness.
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.
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.
Circadian typology score
Using a standardized questionnaire: Horne & Östberg questionnaire. Score ranging from 16 to 86, higher score denoting morningness and lower score eveningness.
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®.
Sleep eye movements
Using power spectral sleep EOG analysis (left and right) with Titanium, Embla®, NOX-A1®.
Sleep muscles activity
Using power spectral sleep EMG analysis (chin and anterior tibialis muscle) with Titanium, Embla®, NOX-A1®
Sleep cardiac activity
Using power spectral sleep ECG analysis (P wave, QRS complex, QT interval, PR interval...) with Titanium, Embla®, NOX-A1®.
Sleep oxygen saturation
Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®.
Sleep airflow
Using sleep airflow measures with Titanium, Embla®, NOX-A1®.
Sleep respiratory efforts
Using abdominal and thoracic respiratory efforts measures with Titanium, Embla®, NOX-A1®.
Snoring
Using snoring measures with Titanium, Embla®, NOX-A1®.

Full Information

First Posted
June 2, 2023
Last Updated
September 28, 2023
Sponsor
Chantal Berna Renella
Collaborators
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT05953207
Brief Title
Non-pharmacological Treatments for Parasomnias
Official Title
Evaluation of the Efficacy of Non-pharmacological Treatments for Parasomnias: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chantal Berna Renella
Collaborators
University of Lausanne Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NREM Parasomnia
Keywords
Medical hypnosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical hypnosis (HYP)
Arm Type
Experimental
Arm Description
3 medical hypnosis interventions
Arm Title
Standard Of Care (SOC)
Arm Type
Active Comparator
Arm Description
3 standard of care quality and sleep safety interventions
Intervention Type
Other
Intervention Name(s)
Medical hypnosis
Intervention Description
Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation)
Intervention Type
Other
Intervention Name(s)
Standard Of Care
Intervention Description
Sleep hygiene and safety education session
Primary Outcome Measure Information:
Title
Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
Description
Parasomniac episodes scored on infrared home video recording
Time Frame
Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at 9 weeks) the treatment
Secondary Outcome Measure Information:
Title
Duration of parasomniac episodes
Description
Using home video recording
Time Frame
Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) treatment
Title
Rate of confusional arousals, sleepwalking and sleep terrors episodes
Description
Categorization of parasomniac episodes' complexity (confusional arousals, sleepwalking, sleep terrors) using home video recording
Time Frame
Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) the treatment
Title
Incidence of emotions related to parasomniac episodes
Description
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?)
Time Frame
Through study duration, an average of 9 weeks
Title
Quality of life score
Description
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.
Time Frame
At Day 0, Week 11 and Week 18
Title
Anxiety and depression scores
Description
Using a standardized questionnaire: Hospital Anxiety and Depression Scale (HADS). Subscale score ranging from 3 to 21, score >8 denotes anxiety or depression.
Time Frame
At Day 0 and Week 11
Title
Traumatic events score
Description
Using a standardized questionnaire: Life Event Checklist for DSM-5 (LEC-5). It does not yield a total score or a composite score.
Time Frame
At Day 0
Title
Fatigue score
Description
Using a standardized questionnaire: Pichot's fatigue scale. Score ranging from 0 to 32, score >22 denotes excessive fatigue.
Time Frame
At Week 2, Week 11 and Week 18
Title
Sleepiness score
Description
Using a standardized questionnaire: Epworth Sleepiness Scale (ESS). Score ranging from 0 to 24, higher score denoting higher daytime sleepiness.
Time Frame
At Week 2, Week 11 and Week 18
Title
Sleep quality score
Description
Using a standardized questionnaire: Pittsburgh Sleep Quality Index (PSQI). Score ranging from 0 to 21, higher score denoting greater acute sleep disturbances.
Time Frame
At Week 2, Week 11 and Week 18
Title
Severity of arousal disorders score
Description
Using a standardized questionnaire: Paris Arousal Disorders Severity Scale (PADSS). Score ranging from 0 to 50, higher score denoting more severed disorders.
Time Frame
At Week 2, Week 11 and Week 18
Title
Circadian typology score
Description
Using a standardized questionnaire: Horne & Östberg questionnaire. Score ranging from 16 to 86, higher score denoting morningness and lower score eveningness.
Time Frame
At Week 2, Week 11 and Week 18
Title
Changes in imagery processes
Description
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®.
Time Frame
At Day 0 and Week 11
Title
Sleep eye movements
Description
Using power spectral sleep EOG analysis (left and right) with Titanium, Embla®, NOX-A1®.
Time Frame
At Week 11 (optional)
Title
Sleep muscles activity
Description
Using power spectral sleep EMG analysis (chin and anterior tibialis muscle) with Titanium, Embla®, NOX-A1®
Time Frame
At Week 11 (optional)
Title
Sleep cardiac activity
Description
Using power spectral sleep ECG analysis (P wave, QRS complex, QT interval, PR interval...) with Titanium, Embla®, NOX-A1®.
Time Frame
At Week 11 (optional)
Title
Sleep oxygen saturation
Description
Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®.
Time Frame
At Week 11 (optional)
Title
Sleep airflow
Description
Using sleep airflow measures with Titanium, Embla®, NOX-A1®.
Time Frame
At Week 11 (optional)
Title
Sleep respiratory efforts
Description
Using abdominal and thoracic respiratory efforts measures with Titanium, Embla®, NOX-A1®.
Time Frame
At Week 11 (optional)
Title
Snoring
Description
Using snoring measures with Titanium, Embla®, NOX-A1®.
Time Frame
At Week 11 (optional)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geoffroy Solelhac, Dr.
Phone
+41 79 556 34 48
Email
geoffroy.solelhac@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Rimorini, Msc
Phone
+41 79 556 96 11
Email
nina.rimorini@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Berna Renella, Prof
Organizational Affiliation
CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire vaudois (CHUV)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1005
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffroy Solelhac, MD
Phone
+41 21 314 67 48
Email
geoffroy.solelhac@chuv.ch
First Name & Middle Initial & Last Name & Degree
Nina Rimorini, MSc
Phone
+41 79 556 96 11
Email
nina.rimorini@chuv.ch

12. IPD Sharing Statement

Learn more about this trial

Non-pharmacological Treatments for Parasomnias

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