N/A N=150 Treatment

TPAP for Comfort in OSA

Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT06264128 ↗

Enrolled (actual)

150

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O — 69.3 percentage of total participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TPAP (Device); CPAP (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SleepRes Inc.
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O	69.3	—
PRIMARY CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O	84	—
SECONDARY CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O	45.6	—
SECONDARY CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O	56	—
SECONDARY CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O	45.8	—
SECONDARY CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O	38.5	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06264128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.