Comparing proactive and conventional therapy for sleep apnea
Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea
This study tests if a new AI-powered sleep device helps people with sleep apnea stick to their treatment better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | NovaResp Technologies Inc Industry-sponsored |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06319482 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the adherence to Positive Airway Pressure (PAP) therapy in newly diagnosed patients with obstructive sleep apnea (OSA). Participants will be randomly assigned to receive either proactive therapy using an AI-modified APAP device or conventional APAP therapy. The study will track adherence and health outcomes over a period of 12 months, with regular contact from a sleep technician. Data will be collected through the PAP devices and self-reported questionnaires to assess the effectiveness of each therapy approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a new diagnosis of moderate to severe obstructive sleep apnea.
Not a fit: Patients with prior use of PAP machines or those with severe cardiovascular or neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve adherence to sleep apnea therapy, leading to better health outcomes for patients.
How similar studies have performed: Other studies have shown promise in improving adherence to sleep apnea therapies, but the use of AI in proactive therapy is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Halifax, Nova Scotia
- NovaResp Technologies Inc. — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: Megan Neil, BScN
- Email: megan.neil@novaresp.com
- Phone: 902-986-1660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.