Level 3 Validation Study
ConditionObstructive Sleep Apnea (OSA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWindsor Sleep Disorders Clinic
About this trial
This study will compare the output of a new Level 3 polysomnography system against in-laboratory polysomnography.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Referred for a diagnostic sleep study
Disqualifiers
under the age of 18
significant cardiopulmonary disease, neuromuscular disease or stroke
other significant sleep disorders
use of opiate medications
Trial design
Design model
Single group
Treatments tested in this trial
Comparison 1: Level 1 Polysomnography: Cadwell/Alice
DeviceGold standard measurement of sleep to compare against.
Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor
DeviceNovel Level 3 test under development.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Sleep Laboratory PatientsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Apneas
Frequency of apneas (events per hour)
Time frame
1 night recording per test2
Oxygen Saturation
Oxygen saturation (%)
Time frame
1 Night recording per testLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: