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

NCT04643782 | Completed Results FDA Device

• 1 other identifier: STU0021444
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 4

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

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single Arm Study

OTHER

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

Device: ANNE Sleep

Interventions

ANNE Sleep DEVICE

ANNE sleep system

Single Arm Study

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Sibel Health Inc.: collaborator

Study Sites (4)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Northwestern Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Carle Foundation Hosipital

Urbana, Illinois, 61801, United States

Location

Central Dupage Hospital (CDH)

Winfield, Illinois, 60190, United States

Location

Related Publications (1)

• 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.

  PMID: 35934926 DERIVED

Results Point of Contact

• Title: Phyllis Zee, MD
• Organization: Northwestern University

SleepSensors@northwestern.edu

312-503-5944

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 25, 2020
• Study Start: May 11, 2021
• Primary Completion: November 17, 2021
• Study Completion: December 27, 2021
• Last Updated: February 14, 2023
• Results First Posted: February 14, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)