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

Obstructive Sleep Apnea of Adult Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643782
• Other study ID #: STU0021444
• Status: Completed
• Phase: N/A
• Start date: May 11, 2021
• Est. completion date: December 27, 2021

Study information

• Verified date: January 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: December 27, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• ANNE Sleep
ANNE sleep system

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Northwestern Lake Forest Hospital	Lake Forest	Illinois
United States	Carle Foundation Hosipital	Urbana	Illinois
United States	Central Dupage Hospital (CDH)	Winfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Sibel Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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