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The goal of this clinical trial is to compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are:
This is a double-blind, randomized controlled superiority trial on newly diagnosed patients with obstructive sleep apnea. Each participant will be provided with a APAP device. The devices assigned to the test group will be modified to deliver the proactive therapy using Artificial Intelligence (AI). Devices assigned to the control group will deliver the conventional APAP therapy. A sleep technician will be in regular contact with participants and track the time spent interacting with each participant. At the conclusion of the first 3 months of the trial, participants who are acceptant to therapy will be asked if they would like to continue participating for an additional 9 months. Data will be collected by the PAP device and a series of self-reported questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proactive CPAP Therapy (Intervention) | Experimental | Patients will undergo CPAP enabled with proactive therapy. |
|
| Conventional APAP Therapy (Control) | Active Comparator | Patients will undergo conventional APAP therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive CPAP Therapy | Device | CPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Calculated as at least 70% compliance (at least 4 hrs), in 30 days | 3-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index | Calculated as the mean number of apnea and hypopnea events throughout the night in events/hr. | 3-12 months |
| CPAP Therapy Usage | Calculated as the mean device usage by the patient throughout the night. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Neil, BScN | Contact | 902-986-1660 | megan.neil@novaresp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovaResp Technologies Inc. | Recruiting | Halifax | Nova Scotia | B3H 4H5 | Canada |
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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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| Conventional APAP Therapy | Device | CPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure. |
|
| 3-12 months |
| Self-assessed sleep outcomes | Patients will be requested to fill out a questionnaire to help evaluate their sleepiness before and after therapy. Scale: Epworth Sleepiness Scale on a 7-point scale, higher values meaning worse outcome. | 3-12 months |
| Self-assessed functional outcomes | Patients will be requested to fill out a questionnaire to help evaluate their functional outcomes of sleep before and after therapy. Scale: Functional Outcomes of Sleep Questionnaire on a 7-point scale, higher values meaning better outcomes. | 3-12 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |