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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04643782
Recruitment Status : Completed
First Posted : November 25, 2020
Last Update Posted : April 12, 2022
Sponsor:
Collaborator:
Sibel Health
Information provided by (Responsible Party):
Phyllis Zee, 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

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Device: ANNE Sleep Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will use ANNE Sleep system during one night of polysomnography recording in sleep lab.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : May 11, 2021
Actual Primary Completion Date : November 17, 2021
Actual Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Comparative diagnosis of ANNE system against Polysomnography [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643782


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Northwestern Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Carle Foundation Hosipital
Urbana, Illinois, United States, 61801
Central Dupage Hospital (CDH)
Winfield, Illinois, United States, 60190
Sponsors and Collaborators
Northwestern University
Sibel Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Phyllis Zee, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT04643782    
Other Study ID Numbers: STU0021444
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases