Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Sleep onset latency (minutes)
研究概览
简要总结
The prevalence of sleep disorders has achieved epidemic proportions in Western countries. Despite this, assessment and treatment of sleep disorders remains infrequent, unattainable, and often costly. Dayzz is aware of the need for easily accessible, user-friendly, and affordable treatment strategies for known sleep conditions. This research proposes a randomized controlled outcome study aimed to validate a, digitized, cost-effective mobile app which assesses and manages insomnia and CPAP adherence in persons with sleep apnea. The app's sleep training protocols recommend life-style and behavioral changes and tracks these changes with the aim of improving sleep and well-being. In this study, the dayzz app digital treatment protocol will be compared to the standard treatment for these sleep conditions by a sleep professional.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21-65 years of age referred to the Carmel Hospital sleep clinic and diagnosed by the clinic physician with either Sleep Apnea (referred for CPAP treatment) or Insomnia.
排除标准
- •Patient age <21 years.
- •Patient who is not a member of Clalit Healthcare services.
- •Persons with insufficient control of the English language required for adequate use of app.
- •Persons with insufficient experience/knowledge and/or use of digital apps/smartphones.
- •Persons with serious medical or psychiatric conditions.
- •Women who are pregnant or breastfeeding.
- •Nighttime shift-workers.
- •Persons who are unable to provide consent due to mental incapacity.
- •Persons referred for evaluation of sleep by Ministry of Transportation (for licensing purposes).
- •Persons with comorbid insomnia and sleep apnea
结局指标
主要结局
Sleep onset latency (minutes)
时间窗: 3 months to 1 year
Number of minutes to fall asleep per night (based on nightly sleep diary)
Sleep efficiency (percent)
时间窗: 3 months to 1 year
(Number of minutes asleep per night/number of minutes in bed per night)\*100 (based on sleep diary data)
Sleep quality
时间窗: 3 months to 1 year
Likert scale of sleep quality between 1 and 10 (based on sleep diary report)
Nightly CPAP use
时间窗: 3 months to 1 year
Minutes of wearing the CPAP mask per night (based on sleep diary report)
Insomnia severity
时间窗: 3 months to 1 year
The Insomnia Severity Index (ISI) is a well-validated 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia over the past month (Morin, 1993). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Total sleep time (minutes)
时间窗: 3 months to 1 year
sleep duration in minutes per night (based on nightly sleep diary)
Wake after sleep onset (minutes)
时间窗: 3 months to 1 year
Number of minutes awake in total per night (based on nightly sleep diary)
Excessive daytime sleepiness
时间窗: 3 months to 1 year
The Epworth Sleepiness Scale (ESS): The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity or their 'daytime sleepiness'.
Sleep symptom screening questionnaire
时间窗: 3 months to 1 year
The Dayzz Sleep Questionnaire is a digitized screening measure that assesses sleep quantity and quality and presence/risk for specific sleep disorders. It is composed of some self-rated items, assessing sleep amounts, sleep quality, excessive sleepiness, and risk factors for sleep-related breathing disorders, symptoms of insomnia and sleep/wake circadian rhythms. The questions are based on the International Classification of Sleep Disorders (3rd Edition; American Academy of Sleep Medicine) diagnostic criteria for four common categories of sleep disorders: Insomnia, Insufficient Sleep Syndrome, Sleep Apnea Disorders, and Circadian Rhythm Sleep-Wake Disorders.
次要结局
- Work productivity(3 months to 1 year)
- Insomnia-related quality of life(3 months to 1 year)
- Sleep Apnea-related Quality of Life-Short form (SAQLI-SF)(3 months to 1 year)
- The WHO-5 Well-being Index (WHO-5)(3 months to 1 year)