Non-pharmacological Treatments for Parasomnias

NCT ID: NCT05953207

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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NREM Parasomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medical hypnosis (HYP)

3 medical hypnosis interventions

Group Type EXPERIMENTAL

Medical hypnosis

Intervention Type OTHER

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

Standard Of Care (SOC)

3 standard of care quality and sleep safety interventions

Group Type ACTIVE_COMPARATOR

Standard Of Care

Intervention Type OTHER

Sleep hygiene and safety education session

Interventions

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Medical hypnosis

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

Intervention Type OTHER

Standard Of Care

Sleep hygiene and safety education session

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

Chantal Berna Renella

OTHER

Sponsor Role lead

Responsible Party

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Chantal Berna Renella

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chantal Berna Renella, Prof

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

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Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Geoffroy Solelhac, Dr.

Role: CONTACT

+41 79 556 34 48

Nina Rimorini, Msc

Role: CONTACT

+41 79 556 96 11

Facility Contacts

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Geoffroy Solelhac, MD

Role: primary

+41 21 314 67 48

Nina Rimorini, MSc

Role: backup

+41 79 556 96 11

Other Identifiers

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CER-VD 2023-01007

Identifier Type: -

Identifier Source: org_study_id

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