Evaluation of the Efficacy of Non-pharmacological Treatments for Parasomnias: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Medical hypnosis (HYP) (N=30)
3 medical hypnosis interventions
干预措施: Medical hypnosis (Other)
Standard Of Care (SOC) (N=30)
3 standard of care quality and sleep safety interventions
干预措施: Standard Of Care (Other)
Healthy volunteers (N=50)
Unique EEG visit resembling the initial study visit of patients with NREM parasomnias
结局指标
主要结局
Change, from pre-treatment, of mean number of parasomniac episodes at 9 weeks
时间窗: 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
次要结局
- 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))
- Changes in sleep architecture(At Day 0 and Week 11)
- Changes in imagery processes(At Day 0 and Week 11 for patients.)
- Validation of the EEG methodology for the imagery processes recordings(At Day 0)
研究者
Chantal Berna Renella
Professor
Centre de Médecine Intégrative et Complémentaire (CEMIC)