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: NCT07751562
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.
Trial opening soon.
Get Notified21 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 4 (AHI4) index 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
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
Residual apnea hypopnea index (calculated with hypopnea associated with 3% desaturations or occurrence of an arousal) 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
Pressure that is delivered by the device for 95% of the usage time
Contact information is provided by the study sponsor or research team.
SleepRes Inc.
Industry
A Randomized Crossover Study of Automatic Positive Airway Pressure (APAP) Treatment Efficacy: Kairos APAP (With KPAP) Versus ResMed AirSense APAP With 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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