TPAP for Comfort in OSA

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: TPAP; Device: CPAP

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37129
      • SleepCenters of Middle Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CPAP v TPAP; Participants will compare CPAP to 2 different levels of TPAP, then will compare 2 levels of TPAP against each other by breathing on each pair of therapies for a minute or so, then deciding which is more comfortable or if they are equivalent.

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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O	Compare the comfort level of CPAP at 9 cmH2O against TPAP dropped by 2+2 cmH2O	All tests conducted in a 20 minute time frame on awake supine patients.
CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O	Compare the comfort level of CPAP at 13 cmH2O against TPAP dropped by 2+3 cmH2O	All tests conducted in a 20 minute time frame on awake supine patients.

Secondary Outcome Measures

Outcome Measure	Time Frame
CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O	All tests conducted in a 20 minute time frame on awake supine patients.
CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O	All tests conducted in a 20 minute time frame on awake supine patients.
CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O	All tests conducted in a 20 minute time frame on awake supine patients.
CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O	All tests conducted in a 20 minute time frame on awake supine patients.

Collaborators and Investigators

• Sponsor: SleepRes Inc.
• Investigators: Principal Investigator: Abinash Joshi, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Actual): May 25, 2024
• Study Completion (Actual): May 25, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: comfort; CPAP
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: TheraPAP Comfort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We only plan to share the results after we publish them.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No