NCT06319482 The Adherence of Proactive Sleep Apnea Therapy
| NCT ID | NCT06319482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NovaResp Technologies Inc |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-16 |
| Primary Completion | 2025-06-16 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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: 1. To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients. 2. To compare health outcomes (AHI, nightly usage, leak, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.
Eligibility Criteria
Inclusion Criteria: * Must have a new diagnosis of moderate or severe OSA (i.e., AHI \> 15 events/hour). * Must be 18-70 years old. * No history of self-reported, uncontrolled, severe cardiovascular or neurological issues. * Must be able to comply with all study requirements as outlined in the consent form. * Must be able to follow the directions of the study doctor and research team. * Must be able to understand English and be willing to provide informed consent. Exclusion Criteria: * Prior use of PAP machines. * Subjects actively using bi-level PAP or require oxygen therapy. * Subjects who are medically complicated or who are medically unstable ( i.e., cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness). * Potential sleep apnea complications that, in the opinion of the clinician, may affect the health and safety of the participant. * Inability or unwillingness to given written informed consent. * Neuromuscular disease, hypoglossal-nerve palsy,