Level 3 Validation Study

N/ANot Yet RecruitingNCT07688603

Windsor Sleep Disorders Clinic80 enrolled

Overview

This study will compare the output of a new Level 3 polysomnography system against in-laboratory polysomnography.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea (OSA)

Interventions

Comparison 1: Level 1 Polysomnography: Cadwell/AliceDEVICE

Gold standard measurement of sleep to compare against.

Comparison 2: Level 3 Test: Berry Sleep Apnea Screening MonitorDEVICE

Novel Level 3 test under development.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Referred for a diagnostic sleep study Exclusion Criteria: * under the age of 18 * significant cardiopulmonary disease, neuromuscular disease or stroke * other significant sleep disorders * use of opiate medications

Outcomes

Primary Outcomes

Apneas

Frequency of apneas (events per hour)

Time frame: 1 night recording per test

Oxygen Saturation

Oxygen saturation (%)

Time frame: 1 Night recording per test

Data from ClinicalTrials.gov

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