Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Northwestern University
With
Sibel Health Inc.
The main object of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNE Sleep system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea
Age
22–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. ≥22 years old.
2. Subjects with suspected OSA based on history and physical who qualify for, and have either a PSG or HSAT ordered, as determined by their regular provider. Subjects with self-reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. Persons with a previous diagnosis of OSA are also eligible.
3. Willingness to give written consent and comply with study procedures
You may not be if
1. An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection
2. Inability to understand instructions
3. Has a skin abnormality that precludes assessment
4. Has a history of dementia
5. Patients with implanted pacemakers or defibrillators
6. Subject is pregnant, nursing or planning a pregnancy over the expected course of the study
Clareo Health | Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea
