Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study (ROSA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Validation with gold-standard polysomnography (PSG) recording
研究概览
简要总结
The investigators will conduct this study to validate Belun Ring for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab polysomnography (PSG) measures of SDB and sleep architecture in adults with OSA symptoms.
The investigators propose to recruit a total of 40 participants with symptoms of obstructive sleep apnea. The investigators will i) validate the overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture, using PSG analysis as a gold standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 80 years old. Ideally balanced for sex and age (18 to 80 years old)
- •No more than 75% of subjects in one bin of: (male, female)
- •No more than 50% of subjects in one age-group (18-29, 30-39, 40-49, 50-59, 60-80)
- •Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)
- •Without any unstable medical or psychiatric co-morbidities that would be expected to interfere with the study.
- •If taking any medication, must be on a stable dose of medication for a month
- •Able to read and understand English
排除标准
- •Presence of any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol, suicidality, current regular use of psychiatric medications, opiates, or thyroid medications, dementia, current substance abuse, post-traumatic or psychotic disorders, bipolar disorder; any significant neurologic disease, including possible and probable dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma, history of alcohol or substance use disorder within the past 2 years (DSM V criteria);
- •If positive airway pressure (PAP) titration study or split night study (diagnostic and PAP titration study combined)
- •Under 18 or over 80 years of age
结局指标
主要结局
Validation with gold-standard polysomnography (PSG) recording
时间窗: through study completion, an average of 1 year
Concordance rate of respiratory disturbance index (RDI) from Belun Ring and apnea-hypopnea Index (AHI) from PSG
次要结局
未报告次要终点
研究者
Makoto Kawai
Clinical Associate Professor
Stanford University