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

Chantal Berna Renella1 site in 1 country60 target enrollmentAugust 30, 2023

ConditionsNREM Parasomnia

Overview

Phase: N/A
Intervention: Not specified
Conditions: NREM Parasomnia
Sponsor: Chantal Berna Renella
Enrollment: 60
Locations: 1
Primary Endpoint: Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

August 30, 2023

End Date

August 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chantal Berna Renella

Responsible Party

Sponsor Investigator

Principal Investigator

Chantal Berna Renella

Professor

Centre de Médecine Intégrative et Complémentaire (CEMIC)

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

Incidence of emotions related to parasomniac episodes(Through study duration, an average of 9 weeks)
Anxiety and depression scores(At Day 0 and Week 11)
Sleep quality score(At Week 2, Week 11 and Week 18)
Duration of parasomniac episodes(Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) treatment)
Quality of life score(At Day 0, Week 11 and Week 18)
Changes in imagery processes(At Day 0 and Week 11)
Sleepiness score(At Week 2, Week 11 and Week 18)
Severity of arousal disorders score(At Week 2, Week 11 and Week 18)
Circadian typology score(At Week 2, Week 11 and Week 18)
Sleep eye movements(At Week 11 (optional))
Sleep oxygen saturation(At Week 11 (optional))
Sleep airflow(At Week 11 (optional))
Sleep respiratory efforts(At Week 11 (optional))
Rate of confusional arousals, sleepwalking and sleep terrors episodes(Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) the treatment)
Traumatic events score(At Day 0)
Fatigue score(At Week 2, Week 11 and Week 18)
Snoring(At Week 11 (optional))
Sleep muscles activity(At Week 11 (optional))
Sleep cardiac activity(At Week 11 (optional))