Clinical trial NCT06319482: The Adherence of Proactive Sleep Apnea Therapy
Official title: Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: NovaResp Technologies Inc
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 outcomes:
measure: Adherence
timeFrame: 3-12 months
Secondary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: 3-12 months
measure: CPAP Therapy Usage
timeFrame: 3-12 months
measure: Self-assessed sleep outcomes
timeFrame: 3-12 months
measure: Self-assessed functional outcomes
timeFrame: 3-12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: NovaResp Technologies Inc.
state: Nova Scotia
Study officials:
References: