Comparative Study of the ANNE One System to Diagnose Obstructive Sleep Apnea
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- STATUS
- Recruiting
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- End date
- Jun 30, 2021
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- participants needed
- 300
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- sponsor
- Northwestern University
Summary
The main objective of this study is to evaluate the accuracy of the ANNETM One system for the diagnosis of obstructive sleep apnea (OSA) in adults.
Description
The main objective of this study is to evaluate the accuracy of the ANNETM One system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNETM One system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea. Our secondary hypothesis is that the ANNETM One system is non-inferior to home sleep apnea tests (HST) in the diagnosis of obstructive sleep apnea for patients who qualified for HST. Exploratory objectives include assessment of the diagnostic yield of the ANNETM One system worn over multiple sequential nights, repeatability of apnea-hypopnea index (AHI) calculations over multiple nights, and the predictive value of pulse arrival time to detect obstructive, central, and mixed apnea and hypopnea events.
Details
| Condition | Obstructive Sleep Apnea of Adult |
|---|---|
| Treatment | ANNE One System |
| Clinical Study Identifier | NCT04643782 |
| Sponsor | Northwestern University |
| Last Modified on | 27 January 2021 |
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