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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 287
- Locations
- 4
- Primary Endpoint
- Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography
Study Overview
Brief Summary
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
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •≥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
Exclusion Criteria
- •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
Arms & Interventions
Single Arm Study
After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.
Intervention: ANNE Sleep (Device)
Outcomes
Primary Outcomes
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography
Time Frame: 1 night
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Phyllis Zee
Principal Investigator
Northwestern University