Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to compare in OSA patients who regularly adhere to CPAP therapy. The main question[s] it aims to answer are:
Participants will undergo the conventional APAP therapy and the new proactive therapy.
Researchers will compare nights in which conventional APAP was used and nights in which proactive therapy was used to see if patients were treated with lower pressures and effectively.
This is a blinded, randomised, crossover, study on patients diagnosed with obstructive sleep apnea who regularly adhere to APAP therapy. Data collection will span 23 consecutive nights for each participant. Participants will use a modified APAP device for 2 periods of 9 nights each, separated by 5 nights in which participants will use their personal APAP device. The modified APAP device is switchable between two therapy modes: a) proactive therapy, and b) conventional APAP therapy. Treatment for the 2 periods will be randomly assigned, with one period as the test period where the proactive therapy is used every night for 9 consecutive nights, and the other as the control period where their conventional APAP therapy (i.e., the participant's regular therapy but on the modified device) is used every night for 9 consecutive nights. Participants will be blinded to the therapy they are receiving during the test and control period. Data will be collected by the modified PAP device and at-home sleep apnea test ring.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention first | Experimental | Patients will undergo proactive therapy first, followed by the buffer period, and finally the conventional APAP therapy. |
|
| Control first | Experimental | Patients will undergo the conventional APAP therapy first, followed by the buffer period, and finally the proactive therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive Therapy | Device | Uses AI to make predictions and preventions of future apneic events. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mask pressure | Calculated as the mean pressure throughout the night. | 18 nights |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index | Calculated as the mean number of apnea and hypopnea events throughout the night, in events/hr. | 18 nights |
| Comfort score | Questionnaire that measures comfort of therapy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 18 nights |
| Sleepiness self-assessment | Patients will be requested to fill out a questionnaire to help evaluate their sleepiness after the treatment period and control period | 18 nights |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |