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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APAP + KPAP | Experimental | Auto-adjusting positive airway pressure + Kairos positive airway pressure |
|
| 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 |
|---|---|---|
| Subjective comfort | This outcome will be evaluated through a 10 point Visual Analog Scale (VAS) | This outcome will be evaluated after 4 days of treatment in each arm |
| Measure | Description | Time Frame |
|---|---|---|
| P95 | Pressure delivered by the device for 95% of the time. It will be downloaded from the device. | This outcome will be evaluated after 4 days of treatment in each arm |
| Residual AHI | Apnea hypopnea index downloaded from the device |
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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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| 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 4 days of treatment in each arm |
| Adherence (in average h/night) | Use of the device per night downloaded from the device | This outcome will be evaluated after 4 days of treatment in each arm |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |