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NCT Number: NCT07751562

KPAP vs AirSense 11 With EPR

The KPAP vs AirSense 11 with EPR study is a randomized, crossover study in which treatment efficacy will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be chosen from those with a formal OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) within the past 2 years and on PAP therapy.

Upon signing an informed consent, participants will be randomized to the order of study and which device will be used first: APAP + KPAP (delivered by a SleepRes device) or APAP + EPR (delivered by a ResMed device). Participants will be blinded to the sequence order. They will then be invited to the laboratory for two overnight sleep studies, one on each treatment device, in the order determined by the randomization. Prior to each overnight, they will have to observe withdrawal of their home PAP treatment for 3 nights. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP from both manufacturers will be set on a 5-20 cmH2O pressure range. The next morning of each sleep study, participants will be administered visual analog scale (VAS) questionnaires to examine subjective sleep quality (1=best sleep quality; 10=worst sleep quality) and, after all studies are completed, a device subjective preference (1=APAP+KPAP was extremely better than APAP+EPR; 10=the opposite).

The study will be single blinded with both the participants (the device will be concealed in the laboratory so that participants will not be able to understand what treatment they are on) and the registered technician scoring the polysomnograms (by an independent scoring partner, Sleep Strategies) blinded to treatment allocation.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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
  • Diagnosis of OSA meeting all the following criteria: AHI4 > 10 on a previous PSG or HST (within the past 2 years), central apneas < 25% of events, PLM arousal index < 15 if recorded
  • Current treatment with PAP of any nightly duration.
  • 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.
  • Prior/Concomitant Therapy including: chronic nocturnal oxygen therapy, mandibular advancement device, active hypoglossal nerve stimulation implant.
  • Excessive alcohol consumption (>21 drinks/week).
  • The use of any illegal drug(s).

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. Treatment efficacy

    Time frame: This outcome will be evaluated after one night of treatment

    Per residual apnea hypopnea 4 (AHI4) index determined through an in-laboratory polysomnography

Secondary outcomes

  1. Sleep efficiency

    Time frame: This outcome will be evaluated after one night of treatment

    Time asleep divided by time in bed determined through an in-laboratory polysomnography

  2. Total sleep time

    Time frame: This outcome will be evaluated after one night of treatment

    Amount of sleep in min determined through an in-laboratory polysomnography

  3. AHI3a

    Time frame: This outcome will be evaluated after one night of treatment

    Residual apnea hypopnea index (calculated with hypopnea associated with 3% desaturations or occurrence of an arousal) determined through an in-laboratory polysomnography

  4. Leak

    Time frame: This outcome will be evaluated after one night of treatment

    Per leak calculated by and downloaded from the device

  5. Next-morning subjective sleep quality

    Time frame: This outcome will be evaluated after one night of treatment

    Per 10-point Visual Analog Scale

  6. Next-morning device preference

    Time frame: This outcome will be evaluated after one night of treatment

    Per 10-point Visual Analog Scale

  7. P95

    Time frame: This outcome will be evaluated after one night of treatment

    Pressure that is delivered by the device for 95% of the usage time

Study contacts

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

William H Noah, MD

CONTACT

[email protected]

6153946624

Sponsors and collaborators

Lead sponsor

SleepRes Inc.

Industry

Registry information

Official study title

A Randomized Crossover Study of Automatic Positive Airway Pressure (APAP) Treatment Efficacy: Kairos APAP (With KPAP) Versus ResMed AirSense APAP With EPR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2026
Registry last updated
Aug 7, 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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