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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-11

Study Completion Date

2021-12-27

Brief Summary

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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

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Detailed Description

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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

Conditions

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Obstructive Sleep Apnea of Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm Study

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

Group Type OTHER

ANNE Sleep

Intervention Type DEVICE

ANNE sleep system

Interventions

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ANNE Sleep

ANNE sleep system

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes