CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
TPAP +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.

Search/NCT06264128
NCT06264128N/ACompleted

The Effect on Subjective Comfort of a Device Providing Positive Airway Pressure (PAP) Drops During Inspiration (TPAP) Compared to Continuous Positive Airway Pressure (CPAP) in Obstructive Sleep Apnea Patients

SleepRes Inc.·interventional·Posted Feb 16, 2024·Updated Dec 11, 2024

In Brief

A clinical study evaluating TPAP and CPAP for Obstructive Sleep Apnea. Completed, enrolled 150 participants across 1 site.

Detailed Summary

TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what is called TPAP . TPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. The present study, TheraPAP Comfort, aims at assessing whether TPAP improves patient comfort vs. CPAP during supine wakefulness.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedFeb 16, 2024
Enrollment StartMar 8, 2024
Primary CompletionMay 25, 2024
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.4 years ago

Interventions

TPAPdevice

TPAP is a form of CPAP therapy where the therapy pressure is reduced from the beginning of inhalation through mid or later exhalation. The "CPAP" therapy pressure is only present at the end of the expiratory phase.

CPAPdevice

CPAP is a standard formal at home therapy for obstructive sleep apnea where a device attached via a facemask applies a constant pressure to a patient's lungs during sleep. It is the reference standard in this study.