Development and Online Evaluation of an Online Course for Parasomnias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- self-reported parasomnia severity
研究概览
简要总结
Parasomnias are unwanted events during sleep. These refer to sleep terrors, sleepwalking, sleep eating, nightmares, and movement during REM sleep. There are few systematic behavioral treatments for these problems and individuals with them often receive little education about self-management. This research examines and evaluates the effectiveness of a 4 week online course providing education and guidance about managing parasomnias. The primary outcomes are improvement in parasomnia frequency and distress. The secondary outcomes are improvements in work and social adjustment, mood, anxiety, stress level, fatigue, sleepiness, insomnia, and cognitive interference.
详细描述
Parasomnia disorders are prevalent and impactful conditions, however, there are challenges with disseminating evidence-based interventions for these problems. The rationale for this project is to deliver an online evidence-based course for parasomnias to adults with these disorders to provide education and help for these conditions. The objectives are to determine whether participation in the course reduces the frequency and severity of parasomnias, as evaluated using a sleep diary. Study hypotheses are as follows: a) those receiving the course compared to sleep hygiene education will have a reduction in frequency and severity of parasomnias; b) those receiving the online course compared to sleep hygiene education will have a reduction in sleepiness, fatigue, insomnia, perceived cognitive interference, depression, anxiety, stress, and work and social life interference.
This is a single-blind, randomized controlled trial with two conditions (online course, sleep hygiene education). Participants will be 20 adult outpatients referred to the Behavioral Sleep Medicine Clinic at the Health Sciences Center for treatment of a parasomnia.
Participants will be recruited off the waiting list of an outpatient Behavioral Sleep Medicine Clinic. A research coordinator will screen eligible participants over the telephone and obtain informed consent. Following this, participants will be given a study ID# and link to a pre-treatment survey. Once survey materials have been submitted, participants will be randomized to the online course or to weekly sleep hygiene newsletter, through an automated randomization service. Both groups will monitor their sleep throughout the study using a sleep diary (daily), and complete several questionnaires (weekly). The online course will consist of 4 weekly virtual logins and review of material. The control group will consist of receipt of weekly sleep hygiene tips communicated through a newsletter. At the end of 4 weeks, and at a 2 month follow-up, the surveys will be re-administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physician referred for parasomnia
- •meet criteria for parasomnia on the Structured Clinical Interview for Sleep Disorders (SCISD-R)
- •age >= 18 years
- •parasomnia duration >= 6 months
- •English reading, sighted
- •access to device.
排除标准
- •currently taking one of Lithium, Thioridazine, Chlorpromazine, Perphenazine, Methaqualone, Amitriptyline, Selective Serotonin Re-Uptake Inhibitors, Serotonin and Norepinephrine Re-Uptake inhibitors, or Zopiclone
- •seizure or major neurological disorder
- •untreated sleep apnea, restless legs syndrome, or narcolepsy
研究组 & 干预措施
Sleep hygiene control
Sleep Hygiene Education
干预措施: Sleep Hygiene Control (Behavioral)
Parasomnia Education
Parasomnia Education
干预措施: Parasomnia Education (Behavioral)
结局指标
主要结局
self-reported parasomnia severity
时间窗: baseline, week 4, week 6
sleep diary recorded parasomnia severity rating (from 0 to 3, with 3 being most severe)
self-reported parasomnia frequency
时间窗: baseline, week 4, week 6
frequency of parasomnia events per week (0 to 100)
次要结局
- Secondary measures(baseline, week 4, week 6)
- Sleepiness(baseline, week 4, week 6)
- Insomnia Severity(baseline, week 4, week 6)
- NREM parasomnia symptoms(baseline, week 4, week 6)
- REM parasomnia symptoms(baseline, week 4, week 6)
- nightmare frequency and severity(baseline, week 4, week 6)
- Daytime consequences of parasomnias(baseline, week 4, week 6)
- Work and Social Interference(baseline, week 4, week 6)
- Perceived Cognition(baseline, week 4, week 6)
- Mental Health Symptoms(baseline, week 4, week 6)
研究者
Dr. Nora Vincent
Psychologist, Professor
University of Manitoba