Actively Recruiting
The Adherence of Proactive Sleep Apnea Therapy
Led by NovaResp Technologies Inc · Updated on 2024-10-04
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Adherence of Proactive Sleep Apnea Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Prior use of PAP machines.
- Subjects actively using bi-level PAP or require oxygen therapy.
- Subjects who are medically complicated or unstable (e.g., cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness).
- Potential sleep apnea complications that may affect participant health and safety.
- Inability or unwillingness to give 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 6 months), persistent uncontrolled hypertension despite medication, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound sleep assessment.
- Pregnancy, planning to become pregnant, or breastfeeding.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NovaResp Technologies Inc.
Halifax, Nova Scotia, Canada, B3H 4H5
Actively Recruiting
Research Team
M
Megan Neil, BScN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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