Level 3 Validation Study

Comparison of Home Level 3 Polysomnography to In-Laboratory Polysomnography

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07688603

Enrollment

Registered

2026-07-07

Start date

2026-06-01

Completion date

2026-11-01

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA)

Brief summary

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

Interventions

DEVICEComparison 1: Level 1 Polysomnography: Cadwell/Alice

Gold standard measurement of sleep to compare against.

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

Novel Level 3 test under development.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Apneas	1 night recording per test	Frequency of apneas (events per hour)
Oxygen Saturation	1 Night recording per test	Oxygen saturation (%)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026