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OpenTrials
Completed

NCT Number: NCT06264128

TPAP for Comfort in OSA

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SleepCenters of Middle Tennessee

Murfreesboro, Tennessee, 37129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O

    Time frame: All tests conducted in a 20 minute time frame on awake supine patients.

    Compare the comfort level of CPAP at 9 cmH2O against TPAP dropped by 2+2 cmH2O

  2. CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O

    Time frame: All tests conducted in a 20 minute time frame on awake supine patients.

    Compare the comfort level of CPAP at 13 cmH2O against TPAP dropped by 2+3 cmH2O

Secondary outcomes

  1. CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O

    Time frame: All tests conducted in a 20 minute time frame on awake supine patients.

  2. CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O

    Time frame: All tests conducted in a 20 minute time frame on awake supine patients.

  3. CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O

    Time frame: All tests conducted in a 20 minute time frame on awake supine patients.

  4. CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O

    Time frame: All tests conducted in a 20 minute time frame on awake supine patients.

Sponsors and collaborators

Lead sponsor

SleepRes Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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