The Adherence of Proactive Sleep Apnea Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Proactive CPAP Therapy; Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Neil, BScN; Phone Number: 902-986-1660; Email: megan.neil@novaresp.com

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4H5
      • Recruiting
      • NovaResp Technologies Inc.
      • Contact: Rachelle Lalande, BSc; Phone Number: 902-293-8783; Email: lalande@novaresp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proactive CPAP Therapy (Intervention); Patients will undergo CPAP enabled with proactive therapy.	Device: Proactive CPAP Therapy; CPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure.
Active Comparator: Conventional APAP Therapy (Control); Patients will undergo conventional APAP therapy.	Device: Conventional APAP Therapy; CPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Calculated as at least 70% compliance (at least 4 hrs), in 30 days	3-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index	Calculated as the mean number of apnea and hypopnea events throughout the night in events/hr.	3-12 months
Self-assessed sleep outcomes	Patients will be requested to fill out a questionnaire to help evaluate their sleepiness before and after therapy. Scale: Epworth Sleepiness Scale on a 7-point scale, higher values meaning worse outcome.	3-12 months
Self-assessed functional outcomes	Patients will be requested to fill out a questionnaire to help evaluate their functional outcomes of sleep before and after therapy. Scale: Functional Outcomes of Sleep Questionnaire on a 7-point scale, higher values meaning better outcomes.	3-12 months
CPAP Therapy Usage	Calculated as the mean device usage by the patient throughout the night.	3-12 months

Collaborators and Investigators

• Sponsor: NovaResp Technologies Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2024
• Primary Completion (Estimated): June 16, 2025
• Study Completion (Estimated): June 16, 2025

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Adherence Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No