Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264128
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-02
Brief Title:
TPAP for Comfort in OSA
Sponsor:
SleepRes Inc
Organization:
SleepRes Inc
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The TheraPAP Comfort Study is an in-office study to assess comfort of TPAP vs CPAP in CPAP-naïve patients with OSA during supine wakefulness Patients will be recruited after routine outpatient visits They will be asked to breath normally for approximately 1 minute in supine wakefulness while being administered background CPAP at 9 or 13 cmH2O or TPAP at various pressure drops TPAP drops will be administered in a paired comparison before orand after each corresponding CPAP level according to a randomized design Eventually 6 one-to-one comparisons TPAP vs corresponding background CPAP or TPAP vs TPAP will be made 3 per each randomized order As an example CPAP 9 will be compared to TPAP 11 cmH2O drops CPAP 9 will be compared to TPAP 22 cmH2O drops and TPAP 11 cmH2O drops will be compared to TPAP 22 cmH2O drops in a random sequence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None