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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APAP + KPAP | Experimental | Auto-adjusting positive airway pressure + Kairos PAP |
|
| APAP + EPR | Active Comparator | Auto-adjusting positive airway pressure + Expiratory Pressure Relief |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy | Per residual apnea hypopnea index determined through an in-laboratory polysomnography | This outcome will be evaluated after one night of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Leak | Per leak calculated by and downloaded from the device | This outcome will be evaluated after one night of treatment |
| Next-morning subjective sleep quality | Per 10-point Visual Analog Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Noah, MD | Contact | 6153946624 | whnoah@sleepres.com |
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We only plan to share the results after we publish them
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Also the scorer of the studies will be blinded to treatment allocation
| APAP + EPR | Device | A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3 |
|
| This outcome will be evaluated after one night of treatment |
| Next-morning subjective device preference | Per 10-point Visual Analog Scale | This outcome will be evaluated after one night of treatment |
| Sleep onset latency | Time that it takes for sleep to onset determined through an in-laboratory polysomnography | This outcome will be evaluated after one night of treatment |
| Total sleep time | Amount of sleep in min determined through an in-laboratory polysomnography | This outcome will be evaluated after one night of treatment |
| Sleep efficiency | Time asleep divided by time in bed determined through an in-laboratory polysomnography | This outcome will be evaluated after one night of treatment |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |