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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea of Adult
• Interventions: Device: ANNE Sleep

• Registration Number: NCT04643782
• Lead Sponsor: Northwestern University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Study Start: 2021-05-11
• Primary Completion: 2021-11-17
• Study Completion: 2021-12-27
• Results First Submitted: 2022-11-15
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Results First Posted: 2023-02-14
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study	ANNE Sleep	After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography	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.

Trial Locations

Locations (4)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Northwestern Lake Forest Hospital; 🇺🇸 Lake Forest, Illinois, United States

Central Dupage Hospital (CDH); 🇺🇸 Winfield, Illinois, United States

Carle Foundation Hosipital; 🇺🇸 Urbana, Illinois, United States