A Validation Study of the NightOwl Home Sleep Apnea Test
- Conditions
- Sleep Apnea
- Registration Number
- NCT04764734
- Lead Sponsor
- Ectosense NV
- Brief Summary
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the apnea hypopnea index (AHI) estimate, defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. This study will be performed in a sleep lab environment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Subjects with an indication for an in-lab polysomnography
- Intellectually disabled people
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization Through study completion, an average of 1 month. The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (4)
Coral Springs Laboratory
🇺🇸Coral Springs, Florida, United States
United Sleep Diagnostics Hollywood Laboratory
🇺🇸Hollywood, Florida, United States
Miami Lakes Laboratory
🇺🇸Miami Lakes, Florida, United States
United Sleep Diagnostics Pembroke Pines Laboratory
🇺🇸Pembroke Pines, Florida, United States
Coral Springs Laboratory🇺🇸Coral Springs, Florida, United States