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NCT Number: NCT07530510

KPAP vs EPR for Comfort

The KPAP EPR Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be individuals with newly diagnosed OSA who have not previously tried any PAP treatment (PAP-naïve).

Upon signing an informed consent, participants will be randomized to receiving either APAP + KPAP (delivered by a SleepRes device) or APAP + EPR (delivered by a ResMed device) for home use. Participants will be asked to use the devices (in the order of randomization) for 4 days each, with 3 days of washout in between. Participants will be blinded to the sequence order, even though they will receive machines that are not identical at each treatment. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP will be set on the full pressure range (i.e., 5-20 cmH2O). After each period, each individual will be asked to rate their device preference according to a 10-point visual analog (VAS) scale (i.e., 1=extremely uncomfortable treatment; 10=extremely comfortable treatment). After usage, the devices will be returned to the office and device data will be downloaded.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI above 18 kg/m2, inclusive
  • Recent formal diagnosis of OSA meeting all the following criteria: AHI > 10, Central apneas < 25% of events, PLM arousal index < 15, no prior/concomitant OSA therapy
  • Subject is fluent in English and subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
  • Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the study-related procedures.

Exclusion criteria

  • A female of child-bearing potential that is pregnant or intends to become pregnant.
  • Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).
  • Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.
  • The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc.).
  • The presence of a psychiatric disorder, including attempted suicide within 1 year prior to screening, or current suicidal ideation.
  • A serious illness or infection in the past 30 days.
  • Excessive alcohol consumption (>21 drinks/week).
  • The use of any illegal drug(s).
  • 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

APAP + KPAP

Device

A SleepRes device will deliver auto-adjusting positive airway pressure (APAP) + Kairos PAP at the maximum drop (1, 2, 3, 4, 5 cmH2O at background pressures of 6, 7, 8, 9, 10 cmH2O, respectively)

APAP + EPR

Device

A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3

Primary outcomes

  1. Subjective comfort

    Time frame: This outcome will be evaluated after 4 days of treatment in each arm

    This outcome will be evaluated through a 10 point Visual Analog Scale (VAS)

Secondary outcomes

  1. P95

    Time frame: This outcome will be evaluated after 4 days of treatment in each arm

    Pressure delivered by the device for 95% of the time. It will be downloaded from the device.

  2. Residual AHI

    Time frame: This outcome will be evaluated after 4 days of treatment in each arm

    Apnea hypopnea index downloaded from the device

  3. Adherence (in average h/night)

    Time frame: This outcome will be evaluated after 4 days of treatment in each arm

    Use of the device per night downloaded from the device

Study contacts

Contact information is provided by the study sponsor or research team.

William Noah, MD

CONTACT

[email protected]

6153946624

Sponsors and collaborators

Lead sponsor

SleepRes Inc.

Industry

Registry information

Official study title

A Randomized Crossover Study of Subjective Comfort With At-Home Auto-Titrating Positive Airway Pressure (APAP): Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

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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