Clinical trial NCT05953207: Non-pharmacological Treatments for Parasomnias
Official title: Evaluation of the Efficacy of Non-pharmacological Treatments for Parasomnias: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NREM Parasomnia
Keywords: Medical hypnosis
Lead sponsor: Centre de Médecine Intégrative et Complémentaire (CEMIC)
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2023-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
timeFrame: Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at 9 weeks) the treatment
Secondary outcomes:
measure: Duration of parasomniac episodes
timeFrame: Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) treatment
measure: Rate of confusional arousals, sleepwalking and sleep terrors episodes
timeFrame: Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at Week 9) the treatment
measure: Incidence of emotions related to parasomniac episodes
timeFrame: Through study duration, an average of 9 weeks
measure: Quality of life score
timeFrame: At Day 0, Week 11 and Week 18
measure: Anxiety and depression scores
timeFrame: At Day 0 and Week 11
measure: Traumatic events score
timeFrame: At Day 0
measure: Fatigue score
timeFrame: At Week 2, Week 11 and Week 18
measure: Sleepiness score
timeFrame: At Week 2, Week 11 and Week 18
measure: Sleep quality score
timeFrame: At Week 2, Week 11 and Week 18
measure: Severity of arousal disorders score
timeFrame: At Week 2, Week 11 and Week 18
measure: Circadian typology score
timeFrame: At Week 2, Week 11 and Week 18
measure: Changes in imagery processes
timeFrame: At Day 0 and Week 11
measure: Sleep eye movements
timeFrame: At Week 11 (optional)
measure: Sleep muscles activity
timeFrame: At Week 11 (optional)
measure: Sleep cardiac activity
timeFrame: At Week 11 (optional)
measure: Sleep oxygen saturation
timeFrame: At Week 11 (optional)
measure: Sleep airflow
timeFrame: At Week 11 (optional)
measure: Sleep respiratory efforts
timeFrame: At Week 11 (optional)
measure: Snoring
timeFrame: At Week 11 (optional)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois (CHUV)
state: Vaud
Study officials:
affiliation: CHUV
name: Chantal Berna Renella, Prof
role: PRINCIPAL_INVESTIGATOR
References: