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

Primary Purpose

Obstructive Sleep Apnea of Adult

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ANNE Sleep

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Northwestern Memorial Hospital
Northwestern Lake Forest Hospital
Carle Foundation Hosipital
Central Dupage Hospital (CDH)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm Study

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04643782

First Posted

November 16, 2020

Last Updated

January 23, 2023

Sponsor

Northwestern University

Collaborators

Sibel Health Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04643782

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

May 11, 2021 (Actual)

Primary Completion Date

November 17, 2021 (Actual)

Study Completion Date

December 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Sibel Health Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea of Adult

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Patients will use ANNE Sleep system during one night of polysomnography recording in sleep lab.

Masking

None (Open Label)

Allocation

N/A

Enrollment

287 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm Study

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

ANNE Sleep

Intervention Description

ANNE sleep system

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 night

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Northwestern Lake Forest Hospital

City

Lake Forest

State/Province

Illinois

ZIP/Postal Code

60045

Country

United States

Facility Name

Carle Foundation Hosipital

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

Facility Name

Central Dupage Hospital (CDH)

City

Winfield

State/Province

Illinois

ZIP/Postal Code

60190

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data stored and used for future research will be de-identified. Data will not be used for future research outside of the scope of this study.

Citations:

PubMed Identifier

35934926

Citation

Davies C, Lee JY, Walter J, Kim D, Yu L, Park J, Blake S, Kalluri L, Cziraky M, Stanek E, Miller J, Harty BJ, Schauer J, Rangel SM, Serao A, Edel C, Ran DS, Olagbenro MO, Lim A, Gill K, Cooksey J, Toloui O, Power T, Xu S, Zee P. A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea. J Clin Sleep Med. 2022 Dec 1;18(12):2703-2712. doi: 10.5664/jcsm.10194.

Results Reference

derived

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

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