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Clinical Trials in Canada / NCT06319482
Recruiting Not applicable

The Adherence of Proactive Sleep Apnea Therapy

NCT06319482 · tracked via the Priya Life Science Canada tracker
Sponsor
NovaResp Technologies Inc
Phase
Not applicable
Started
2024-06-16
Last updated
2024-10-04

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Proactive CPAP TherapyConventional APAP Therapy

Proactive CPAP Therapy: CPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure.

Conventional APAP Therapy: CPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure.

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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, severe restrictive or obstructive pulmonary disease, moderate-to-severe pulmonary arterial hypertension, severe valvular heart disease, New York Heart Association class III or IV heart failure, recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months), persistent uncontrolled hypertension despite medication use, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound functional sleep assessment. * Pregnancy, planning to attempt to become pregnant, or breastfeeding.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
NovaResp Technologies Inc. Halifax Nova Scotia Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06319482 on ClinicalTrials.gov ↗ ← All trials in Canada