The Adherence of Proactive Sleep Apnea Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proactive CPAP Therapy, Conventional APAP Therapy.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea
Overview
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.
Interventions
- Device Proactive CPAP Therapy
CPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure. - Device Conventional APAP Therapy
CPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure.
Primary outcome measures
- Adherence [Time frame: 3-12 months]
Secondary outcome measures (4)
- Apnea-Hypopnea Index [Time frame: 3-12 months]
- CPAP Therapy Usage [Time frame: 3-12 months]
- Self-assessed sleep outcomes [Time frame: 3-12 months]
- Self-assessed functional outcomes [Time frame: 3-12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- NovaResp Technologies Inc. — Halifax
Identifiers
NCT: NCT06319482 · Adherence Study