The Adherence of Proactive Sleep Apnea Therapy

Last updated: October 2, 2024
Sponsor: NovaResp Technologies Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Conventional APAP Therapy

Proactive CPAP Therapy

Clinical Study ID

NCT06319482
Adherence Study
  • Ages 18-70
  • All Genders

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 Criteria

Inclusion

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 neurologicalissues.

  • 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

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, mayaffect the health and safety of the participant.

  • Inability or unwillingness to given written informed consent.

  • Neuromuscular disease, hypoglossal-nerve palsy, severe restrictive or obstructivepulmonary disease, moderate-to-severe pulmonary arterial hypertension, severevalvular heart disease, New York Heart Association class III or IV heart failure,recent myocardial infarction or severe cardiac arrhythmias (within the past 6months), persistent uncontrolled hypertension despite medication use, activepsychiatric disease, and coexisting non-respiratory sleep disorders that wouldconfound functional sleep assessment.

  • Pregnancy, planning to attempt to become pregnant, or breastfeeding.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Conventional APAP Therapy
Phase:
Study Start date:
June 16, 2024
Estimated Completion Date:
June 16, 2025

Study 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.

Connect with a study center

  • NovaResp Technologies Inc.

    Halifax, Nova Scotia B3H 4H5
    Canada

    Active - Recruiting

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