CompletedNCT05953207ClinicalTrials.gov record

Non-pharmacological Treatments for Parasomnias

NREM Parasomnia

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 110 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Exclusion criteria:

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).

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Medical hypnosis (HYP) (N=30)

3 medical hypnosis interventions

Other: Medical hypnosis

Standard Of Care (SOC) (N=30)

3 standard of care quality and sleep safety interventions

Other: Standard Of Care

Healthy volunteers (N=50)

Unique EEG visit resembling the initial study visit of patients with NREM parasomnias

Medical hypnosis OTHER

Hypnosis intervention with specific suggestions (i.e., patient's own dreamlike mentation)

Standard Of Care OTHER

Sleep hygiene and safety education session

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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

Secondary measures

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

Using home video recording

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

Categorization of parasomniac episodes' complexity (confusional arousals, sleepwalking, sleep terrors) using home video recording

Incidence of emotions related to parasomniac episodes

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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