NCT06319482 The Adherence of Proactive Sleep Apnea Therapy
| NCT ID | NCT06319482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NovaResp Technologies Inc |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-16 |
| Primary Completion | 2025-06-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-06-16 with a primary completion date of 2025-06-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06319482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06319482 currently recruiting?
Yes, NCT06319482 is actively recruiting participants. Contact the research team at megan.neil@novaresp.com for enrollment information.
Where is the NCT06319482 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT06319482 clinical trial?
NCT06319482 is sponsored by NovaResp Technologies Inc. The trial plans to enroll 200 participants.