Non-pharmacological Treatments for Parasomnias

NCT05953207 | Unknown

• 1 other identifier: CER-VD 2023-01007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

NREM Parasomnia

Keywords

Medical hypnosis

Outcome Measures

Primary Outcomes (1)

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

  Parasomniac episodes scored on infrared home video recording

  Over a recording period of 10 consecutives nights, 2 weeks before (pre-treatment) and 3 weeks after (at 9 weeks) the treatment

Secondary Outcomes (19)

• 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

• 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

• Incidence of emotions related to parasomniac episodes

  Through study duration, an average of 9 weeks

• Quality of life score

  At Day 0, Week 11 and Week 18

• Anxiety and depression scores

  At Day 0 and Week 11

Study Arms (2)

Medical hypnosis (HYP)

EXPERIMENTAL

3 medical hypnosis interventions

Other: Medical hypnosis

Standard Of Care (SOC)

ACTIVE COMPARATOR

3 standard of care quality and sleep safety interventions

Other: Standard Of Care

Interventions

Medical hypnosis OTHER

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

Medical hypnosis (HYP)

Standard Of Care OTHER

Sleep hygiene and safety education session

Standard Of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chantal Berna Renella: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Chantal Berna Renella, Prof

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffroy Solelhac, Dr.

CONTACT

+41 79 556 34 48; geoffroy.solelhac@chuv.ch

Nina Rimorini, Msc

CONTACT

+41 79 556 96 11; nina.rimorini@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 20, 2023
• Study Start: August 30, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

CH (1)