Level 3 Validation Study

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

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Trial opening soon.

Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparison 1: Level 1 Polysomnography: Cadwell/Alice

Device

Gold standard measurement of sleep to compare against.

Other names: Cadwell, Alice

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

Device

Novel Level 3 test under development.

Other names: Berry Sleep Apnea Screening Monitor

Primary outcomes

Apneas

Time frame: 1 night recording per test

Frequency of apneas (events per hour)
Oxygen Saturation

Time frame: 1 Night recording per test

Oxygen saturation (%)

Sponsors and collaborators

Lead sponsor

Windsor Sleep Disorders Clinic

Other

Registry information

Official study title

Comparison of Home Level 3 Polysomnography to In-Laboratory Polysomnography

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 7, 2026
Registry last updated: Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting