Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea

Northwestern University

Status: Completed

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Device: ANNE Sleep

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04643782

STU0021444

Details and patient eligibility

About

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

Full 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

Enrollment: 287 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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287 participants in 1 patient group

Single Arm Study

Other group

Description:

After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.

Treatment:

Device: ANNE Sleep