Clinical trial NCT06264128: TPAP for Comfort in OSA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: CPAP
comfort
Lead sponsor: SleepRes Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo the same therapy combinations. CPAP (Continuous Positive Airway Pressure) and 2 level of TPAP (TheraPAP - novel CPAP approach pressure is reduced below therapy pressure from inspiration through mid exhalation specifically for comfort) will be assessed against each other in a round robin both backward and forward (6 total binary comparisons) for 2 levels of baseline pressure.
Primary purpose: TREATMENT

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 or/and 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 1/1 cmH2O drops; CPAP 9 will be compared to TPAP 2/2 cmH2O drops; and TPAP 1/1 cmH2O drops will be compared to TPAP 2/2 cmH2O drops in a random sequence.

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:

1. 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).
2. Any chronic lung diseases.
3. Chronic oxygen therapy.
4. A serious illness or infection in the past 30 days as determined by investigator.
5. Patients with hypoglossal nerve stimulation implant.
6. Any non-previously mentioned vulnerable population.
7. 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.

Primary outcomes:
measure: CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O
timeFrame: All tests conducted in a 20 minute time frame on awake supine patients.
measure: CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O
timeFrame: All tests conducted in a 20 minute time frame on awake supine patients.
Secondary outcomes:
measure: CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O
timeFrame: All tests conducted in a 20 minute time frame on awake supine patients.
measure: CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O
timeFrame: All tests conducted in a 20 minute time frame on awake supine patients.
measure: CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O
timeFrame: All tests conducted in a 20 minute time frame on awake supine patients.
measure: CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O
timeFrame: All tests conducted in a 20 minute time frame on awake supine patients.
Other outcomes:
Locations:
city: Murfreesboro
country: United States
facility: SleepCenters of Middle Tennessee
state: Tennessee
Study officials:
affiliation: University of Louisville
name: Abinash Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: