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Clinical Trial 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 pressure, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06319482
Study type Interventional
Source NovaResp Technologies Inc
Contact
Status Not yet recruiting
Phase N/A
Start date April 15, 2024
Completion date August 1, 2025

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