N/A
Completed N=106
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
Source: ClinicalTrials.gov NCT04191668 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Pearson Correlation Between the AHI — 0.909 Correlation coefficient
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 respiratory event index (REI), 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. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pearson Correlation Between the AHI |
0.909 | — |
| PRIMARY Pearson Correlation Between the TST |
0.610 | — |
| PRIMARY The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization |
0.685 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with an indication for an in-lab polysomnography
Exclusion Criteria
- Intellectually disabled people
- People younger than 13 years of age.
Data sourced from ClinicalTrials.gov (NCT04191668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.