APAP + KPAP
DeviceA 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)
NCT Number: NCT07530523
The KPAP EPR is a randomized, crossover study in which treatment efficacy will be compared between SleepRes CPAP + KPAP and ResMed CPAP + EPR. Participants will be chosen from those with a recent OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) and with no previous use of OS therapy (PAP-naïve).
Upon signing an informed consent, participants will be scheduled to come to the sleep laboratory for a manual titration on CPAP. Once the therapeutic pressure is determined, participants will be randomized to start either CPAP + KPAP (delivered by a SleepRes device) or CPAP + 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, with a minimum washout of 1 week and a maximum of 3 weeks. Both studies will use the therapeutic pressure determined during manual titration. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. 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=CPAP+KPAP was extremely better than CPAP+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 polysomnographies blinded to treatment allocation.
Trial opening soon.
Get Notified20 year–80 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3
Time frame: This outcome will be evaluated after one night of treatment
Per residual apnea hypopnea index determined through an in-laboratory polysomnography
Time frame: This outcome will be evaluated after one night of treatment
Per leak calculated by and downloaded from the device
Time frame: This outcome will be evaluated after one night of treatment
Per 10-point Visual Analog Scale
Time frame: This outcome will be evaluated after one night of treatment
Per 10-point Visual Analog Scale
Time frame: This outcome will be evaluated after one night of treatment
Time that it takes for sleep to onset determined through an in-laboratory polysomnography
Time frame: This outcome will be evaluated after one night of treatment
Amount of sleep in min determined through an in-laboratory polysomnography
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
Contact information is provided by the study sponsor or research team.
SleepRes Inc.
Industry
A Randomized Crossover Study of Continuous Positive Airway Pressure (CPAP) Treatment Efficacy: Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)
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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