At a glance
ClinicalIndex Comparison RecordN/ACompleted· 47 enrolled
Drug / intervention
FRESCA mask first night +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
In Brief
A clinical study evaluating FRESCA mask first night and CPAP Mask first night for Obstructive Sleep Apnea and 2 related conditions. Completed, enrolled 47 participants across 5 sites.
Detailed Summary
This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to characterize the clinical performance during a single night of therapy with a FRESCA mask compared with a single night of therapy with their existing nasal Continuous Positive Airway Pressure (CPAP) mask.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea, Sleep Apnea, OSA
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedMar 2015
Primary CompletionSep 2015
Study CompletionOct 2015
TodayJul 2026
First PostedMar 13, 2015
Enrollment StartOct 1, 2014
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.3 years ago
Interventions
FRESCA mask first nightdevice
FRESCA nasal mask first night
CPAP Mask first nightdevice
CPAP Nasal Mask first night