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Not yet recruiting NCT07688603

Level 3 Validation Study

No phase Interventional Obstructive Sleep Apnea (OSA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comparison 1: Level 1 Polysomnography: Cadwell/Alice, Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Home Level 3 Polysomnography to In-Laboratory Polysomnography

Overview

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

Interventions

  • Device Comparison 1: Level 1 Polysomnography: Cadwell/Alice
    Gold standard measurement of sleep to compare against.
  • Device Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor
    Novel Level 3 test under development.

Primary outcome measures

  • Apneas [Time frame: 1 night recording per test]
  • Oxygen Saturation [Time frame: 1 Night recording per test]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07688603 · Level3Validation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗