Obstructive Sleep Apnea of Adult Clinical Trial
Official title:
A Single Arm, Open-Label, Multi-Center, and Comparative Study of the Anne Sleep System Versus Polysomnography to Diagnose Obstructive Sleep Apnea: ANNE Program for the Non-Invasive Evaluation of Apnea in Sleep (APNEAs)
Verified date | January 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 287 |
Est. completion date | December 27, 2021 |
Est. primary completion date | November 17, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: 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 Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Sibel Health Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography | The diagnosis of moderate to severe OSA by determining a patient's Apnea-Hypopnea Index (AHI) using the ANNE Sleep system compared to Polysomnography (PSG) over one (1) night worn concurrently.
Sensitivity is the number of true positives divided by the sum of the number of true positives and false negatives. Specificity is the number of true negatives divided by the sum of the number of true negatives and false positives. |
1 night |
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