CompletadoNCT05953207Registro de ClinicalTrials.gov

Non-pharmacological Treatments for Parasomnias

NREM Parasomnia

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: Aceptados
Participantes: 110 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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).

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks

Plazo: 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

Medidas secundarias

Duration of parasomniac episodes

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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