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

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)

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Device: ANNE Sleep

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 Type: Interventional
• Enrollment (Actual): 287
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Lake Forest, Illinois, United States, 60045
      • Northwestern Lake Forest Hospital
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hosipital
    • Winfield, Illinois, United States, 60190
      • Central Dupage Hospital (CDH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Single Arm Study; After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night.	Device: ANNE Sleep; ANNE sleep system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Sibel Health Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2021
• Primary Completion (ACTUAL): November 17, 2021
• Study Completion (ACTUAL): December 27, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (ACTUAL): November 25, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: STU0021444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes