ANNE Diagnostic Agreement With Home Sleep Testing

Northwestern University38 enrolled

Overview

The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST).

The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST) for the diagnosis of moderate to severe OSA. Other study objectives include: * Determining diagnostic yield from multiple nights and better usability compared to current HST in the intended population. This will include all subjects and a focus on olders 65 and older. * Gathering participant feedback on the use of the sensors and use of the application elicited through focus groups

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea of Adult

Interventions

ANNE SleepDEVICE

ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 22 years old. * Subjects with suspected OSA based on history and physical. 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 based on the opinion of the investigator, this includes but is not limited to: A. Significant cardiorespiratory disease: patients that are oxygen dependent, previous hospitalization for cardiorespiratory issues, or left ventricular ejection fraction ≤ to 40% B. Respiratory muscle weakness due to a neuromuscular condition C. Awake hypoventilation or suspicion of sleep related hypoventilation D. Chronic opioid medication use E. History of stroke F. History of severe insomnia * Inability to understand instructions * Has a skin abnormality that precludes assessment * Has a history of dementia * Patients with implanted pacemakers or defibrillators

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Percent Agreement of ANNE Sleep System to Home Sleep Test (WatchPAT) for Diagnostic Performance to Detect Moderate to Severe Obstructive Sleep Apnea.

To determine the percent agreement between the ANNE sleep system to a Home Sleep Test (WatchPAT) for diagnostic performance to positively detect moderate to severe obstructive sleep apnea.. The WatchPAT system and ANNE sleep were worn for a single night together. The ANNE sleep system was additionally analyzed for up to 3 multiple nights and the data from those nights was pooled to compare against WatchPAT system for positively detecting moderate to severe obstructive sleep apnea.

Time frame: 4 nights

Data from ClinicalTrials.gov

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