TPAP for Comfort in OSA

NCT06264128 | Completed Results FDA Device

• 1 other identifier: TheraPAP Comfort
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

CPAP; comfort

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

Study Arms (1)

CPAP v TPAP

EXPERIMENTAL

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; Device: CPAP

Interventions

TPAP DEVICE

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 v TPAP

CPAP DEVICE

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.

CPAP v TPAP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• SleepRes Inc.: lead

Study Sites (1)

SleepCenters of Middle Tennessee

Murfreesboro, Tennessee, 37129, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Bernie Hete
• Organization: SleepRes

bhete@sleepres.com

+1 615-921-2406

Study Officials

• Abinash Joshi, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is no specific intent to mask although participants will be naive to CPAP-type therapy, but they will be able to feel the difference.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 16, 2024
• Study Start: March 8, 2024
• Primary Completion: May 25, 2024
• Study Completion: May 25, 2024
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)