TPAP for Comfort in OSA

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264128
• Other study ID #: TheraPAP Comfort
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: SleepRes Inc.
• Contact: Bernard Hete, PhD
• Phone: 4123982846
• Email: bhete[@]sleepres.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• TPAP
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.
• CPAP
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.

Locations

Country	Name	City	State
United States	SleepCenters of Middle Tennessee	Murfreesboro	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
SleepRes Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP v TPAP Patient Preference via Visual Analog Scale	Compare the comfort level of CPAP against the comfort of 2 levels of TPAP with different pressure drops by having the patient breathe on CPAP then on the first TPAP level after which they will chose which is more comfortable on a 5 level Likert scale. This will be followed by comparison of breathing on CPAP, then on the second TPAP level after which the preferred comfort will be assessed on the 5 level Likert scale. Pressure comparisons will be conducted both in forward and reverse order separately.	All tests conducted in a 20 minute time frame on awake supine patients.
Secondary	TPAP 1 v TPAP 2 Patient Preference via Visual Analog Scale	The two levels of TPAP tested in Outcome 1 will be tested against each other to see which is more comfortable by breathing on both and having the patient choose the preferred comfort using a VAS based on a 5 level Likert scale. Two comparisons will be made in forward and reverse order.	All still within the 20 minute time frame on awake supine patients. Studies from both outcomes will be run together but fully randomized.