TPAP for Comfort in OSA
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT06264128
- Run by
- SleepRes Inc.
- People needed
- 150
- Starts
- 2024-03-08
- Expected to finish
- 2024-05-25
- Last updated by the study team
- 2024-12-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 - 70 age range
- AHI (apnea/hypopnea index) > 10 on a previous HST (Home Sleep Test)
- CPAP-naive participants
- BMI (Body Mass Index) >= 18 kg/m\^2
You may not qualify if…
- Current clinically significant sleep disorder other than OSA (Obstructive Sleep Apnea) of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central AHI > 5 events/h).
- Any chronic lung diseases.
- Chronic oxygen therapy.
- A serious illness or infection in the past 30 days as determined by investigator.
- Patients with hypoglossal nerve stimulation implant.
- Any non-previously mentioned vulnerable population.
- Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
Where it is running
- SleepCenters of Middle Tennessee — Murfreesboro, Tennessee, United States
Full record on ClinicalTrials.gov
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