Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea begins in USA
The Northwestern University is conducting the Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea.
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. The primary hypothesis is that the ANNETM One system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea. The 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.
It is planned to include 300 participants.
Actual study start date is October 28, 2020. The researchers expect to complete the study by June 30, 2021.
Patients with the following pathologies and conditions:
- An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
- Inability to understand instructions or operate device system.
- Pregnancy, nursing or planning a pregnancy over the expected course of the study.
- Skin abnormality that precludes assessment.
- History of dementia
are excluded from participation.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04643782) Chicago, United States.
