Level 3 Validation Study

July 2, 2026 updated by: Windsor Sleep Disorders Clinic

Comparison of Home Level 3 Polysomnography to In-Laboratory Polysomnography

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep Laboratory Patients
Device: Comparison 1: Level 1 Polysomnography: Cadwell/Alice
Gold standard measurement of sleep to compare against.
Other Names:
  • Cadwell
  • Alice
Device: Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor
Novel Level 3 test under development.
Other Names:
  • Berry Sleep Apnea Screening Monitor

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Windsor Sleep Disorders Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Level3Validation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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