Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Validation with gold-standard polysomnography (PSG) recording
研究概览
简要总结
Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment method. Thus, combining ELAM with PSG will validate ELAM and improve its clinical and research utilization.
The investigators propose to conduct this study to validate ELAM device for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab PSG measures of Sleep-Disordered Breathing (SDB) and sleep architecture in adults with obstructive sleep apnea (OSA) symptoms.
The investigators propose to recruit a total of 40 participants with symptoms of OSA. The overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture will be validated by using PSG analysis as a gold standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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)
结局指标
主要结局
Validation with gold-standard polysomnography (PSG) recording
时间窗: 1 year
Concordance rate of bAHI from Belun Ring and apnea-hypopnea Index (AHI) from PSG
次要结局
未报告次要终点