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NCT Number: NCT05953207

Non-pharmacological Treatments for Parasomnias

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

NREM Parasomnia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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?)

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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®.

  13. Sleep eye movements

    Time frame: At Week 11 (optional)

    Using power spectral sleep EOG analysis (left and right) with Titanium, Embla®, NOX-A1®.

  14. Sleep muscles activity

    Time frame: At Week 11 (optional)

    Using power spectral sleep EMG analysis (chin and anterior tibialis muscle) with Titanium, Embla®, NOX-A1®

  15. Sleep cardiac activity

    Time frame: At Week 11 (optional)

    Using power spectral sleep ECG analysis (P wave, QRS complex, QT interval, PR interval...) with Titanium, Embla®, NOX-A1®.

  16. Sleep oxygen saturation

    Time frame: At Week 11 (optional)

    Using sleep oxygen saturation measures with Titanium, Embla®, NOX-A1®.

  17. Sleep airflow

    Time frame: At Week 11 (optional)

    Using sleep airflow measures with Titanium, Embla®, NOX-A1®.

  18. Sleep respiratory efforts

    Time frame: At Week 11 (optional)

    Using abdominal and thoracic respiratory efforts measures with Titanium, Embla®, NOX-A1®.

  19. Snoring

    Time frame: At Week 11 (optional)

    Using snoring measures with Titanium, Embla®, NOX-A1®.

  20. Changes in imagery processes

    Time frame: At Day 0 and Week 11 for patients.

    Using patients' EEG measures (N=60) collected with a 124-channel waveguardTMoriginal EEG cap and during 3-minute pleasant imagery suggestion audio recordings.

  21. Validation of the EEG methodology for the imagery processes recordings

    Time frame: At Day 0

    Using healthy volunteers' EEG measures (N=50) collected with a 124-channel waveguardTMoriginal EEG and during 5-minute pleasant imagery suggestion audio recordings.

Sponsors and collaborators

Lead sponsor

Chantal Berna Renella

Other

Collaborators

  • University of Lausanne Hospitals

Registry information

Official study title

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

Acronym: Hypnosomnia

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.