NREM ParasomniaHypnosomniaNCT05953207
Non-pharmacological Treatments for Parasomnias
A study testing Medical hypnosis in people with NREM Parasomnia, run by Chantal Berna Renella at 1 site in Switzerland.
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 (N=60). Participants are randomly assigned to one of the two treatments. Treatment consists of 3 sessions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NREM Parasomnia
- What is being tested?
- Medical hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Aug 2023to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Adult (≥ 18 yo) willing and able to give informed consent.
Who cannot join
- 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):
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Canton of Vaud, 1005
About this study
Official title: 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 (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.
Read more
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.
- Conditions
- NREM Parasomnia
- Being tested
- Medical hypnosis, Standard Of Care
- Keywords
- Medical hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical hypnosisOther
Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation)
Standard Of CareOther
Sleep hygiene and safety education session
| Study group | Role | What they receive |
|---|---|---|
| Medical hypnosis (HYP) (N=30) | Experimental | 3 medical hypnosis interventions Receives: Other: Medical hypnosis |
| Standard Of Care (SOC) (N=30) | Active comparator | 3 standard of care quality and sleep safety interventions Receives: Other: Standard Of Care |
| Healthy volunteers (N=50) | No intervention | Unique EEG visit resembling the initial study visit of patients with NREM parasomnias |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
Parasomniac episodes scored on infrared home video recording
Measured: Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at 9 weeks) the treatment
Secondary outcomes (21)
Duration of parasomniac episodes
Using home video recording
Measured: 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
Measured: 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?)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 0
Fatigue score
Using a standardized questionnaire: Pichot's fatigue scale. Score ranging from 0 to 32, score >22 denotes excessive fatigue.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 2, Week 11 and Week 18
Changes in sleep architecture
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®.
Measured: At Day 0 and Week 11
Sleep eye movements
Using power spectral sleep EOG analysis (left and right) with Titanium, Embla®, NOX-A1®.
Measured: At Week 11 (optional)
Sleep muscles activity
Using power spectral sleep EMG analysis (chin and anterior tibialis muscle) with Titanium, Embla®, NOX-A1®
Measured: 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®.
Measured: At Week 11 (optional)
Sleep oxygen saturation
Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®.
Measured: At Week 11 (optional)
Sleep airflow
Using sleep airflow measures with Titanium, Embla®, NOX-A1®.
Measured: At Week 11 (optional)
Sleep respiratory efforts
Using abdominal and thoracic respiratory efforts measures with Titanium, Embla®, NOX-A1®.
Measured: At Week 11 (optional)
Snoring
Using snoring measures with Titanium, Embla®, NOX-A1®.
Measured: At Week 11 (optional)
Changes in imagery processes
Using patients' EEG measures (N=60) collected with a 124-channel waveguardTMoriginal EEG cap and during 3-minute pleasant imagery suggestion audio recordings.
Measured: At Day 0 and Week 11 for patients.
Validation of the EEG methodology for the imagery processes recordings
Using healthy volunteers' EEG measures (N=50) collected with a 124-channel waveguardTMoriginal EEG and during 5-minute pleasant imagery suggestion audio recordings.
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start30 Aug 2023
- Primary completion19 Feb 2026
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NREM ParasomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chantal Berna Renella
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor-investigator, Chantal Berna Renella, Centre de Médecine Intégrative et Complémentaire (CEMIC)
- Investigators
- Chantal Berna Renella, Prof, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953207
- Sponsor's protocol ID
- CER-VD 2023-01007
- Acronym
- Hypnosomnia
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Non-pharmacological Treatments for Parasomnias: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05953207
- Acronym / sponsor ID
- Hypnosomnia / CER-VD 2023-01007
- Conditions
- NREM Parasomnia
- Keywords
- Medical hypnosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Chantal Berna RenellaUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical hypnosis (HYP) (N=30) | Experimental | Other: Medical hypnosis3 medical hypnosis interventions |
| Standard Of Care (SOC) (N=30) | Active comparator | Other: Standard Of Care3 standard of care quality and sleep safety interventions |
| Healthy volunteers (N=50) | No intervention | –Unique EEG visit resembling the initial study visit of patients with NREM parasomnias |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Adult (≥ 18 yo) willing and able to give informed consent.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical hypnosisHypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation) | Other | Medical hypnosis (HYP) (N=30) |
| Standard Of CareSleep hygiene and safety education session | Other | Standard Of Care (SOC) (N=30) |
Primary outcome
Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
Time frame: 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
21 secondary outcomes
Duration of parasomniac episodes
Time frame: 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
Time frame: 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
Time frame: Through study duration, an average of 9 weeks
Quality of life score
Time frame: At Day 0, Week 11 and Week 18
Anxiety and depression scores
Time frame: At Day 0 and Week 11
Traumatic events score
Time frame: At Day 0
Fatigue score
Time frame: At Week 2, Week 11 and Week 18
Sleepiness score
Time frame: At Week 2, Week 11 and Week 18
Sleep quality score
Time frame: At Week 2, Week 11 and Week 18
Severity of arousal disorders score
Time frame: At Week 2, Week 11 and Week 18
Circadian typology score
Time frame: At Week 2, Week 11 and Week 18
Changes in sleep architecture
Time frame: At Day 0 and Week 11
Sleep eye movements
Time frame: At Week 11 (optional)
Sleep muscles activity
Time frame: At Week 11 (optional)
Sleep cardiac activity
Time frame: At Week 11 (optional)
Sleep oxygen saturation
Time frame: At Week 11 (optional)
Sleep airflow
Time frame: At Week 11 (optional)
Sleep respiratory efforts
Time frame: At Week 11 (optional)
Snoring
Time frame: At Week 11 (optional)
Changes in imagery processes
Time frame: At Day 0 and Week 11 for patients.
Validation of the EEG methodology for the imagery processes recordings
Time frame: At Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Berna Renella, Prof principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical hypnosis in people with NREM Parasomnia, run by Chantal Berna Renella at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks (time frame: Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at 9 weeks) the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.