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TPAP for Comfort in OSA

NCT ID: NCT06264128

Last Updated: 2024-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-08

Study Completion Date

2024-05-25

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Keywords

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CPAP comfort

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

TPAP

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SleepRes Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abinash Joshi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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SleepCenters of Middle Tennessee

Murfreesboro, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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TheraPAP Comfort

Identifier Type: -

Identifier Source: org_study_id