NCT06319482

The Adherence of Proactive Sleep Apnea Therapy

Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: NovaResp Technologies Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Proactive CPAP Therapy	CPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure.
DEVICE	Conventional APAP Therapy	CPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure.

Timeline

• Start date: 2024-06-16
• Primary completion: 2025-06-16
• Completion: 2025-06-16
• First posted: 2024-03-20
• Last updated: 2024-10-04

Locations

1 site across 1 country: Canada