Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea of Adult
In brief
The main objective of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults
Key facts
- Study ID
- NCT04643782
- Run by
- Northwestern University
- People needed
- 287
- Starts
- 2021-05-11
- Expected to finish
- 2021-12-27
- Last updated by the study team
- 2023-02-14
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ≥22 years old.
- 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.
- Willingness to give written consent and comply with study procedures
You may not qualify if…
- 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
- Inability to understand instructions
- Has a skin abnormality that precludes assessment
- Has a history of dementia
- Patients with implanted pacemakers or defibrillators
- Subject is pregnant, nursing or planning a pregnancy over the expected course of the study
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Northwestern Lake Forest Hospital — Lake Forest, Illinois, United States
- Carle Foundation Hosipital — Urbana, Illinois, United States
- Central Dupage Hospital (CDH) — Winfield, Illinois, United States
Full record on ClinicalTrials.gov
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