Status:
NOT_YET_RECRUITING
The Comfort of Proactive Sleep Apnea Therapy
Lead Sponsor:
NovaResp Technologies Inc
Conditions:
Obstructive Sleep Apnea
Sleep Apnea
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare in OSA patients who regularly adhere to CPAP therapy. The main question\[s\] it aims to answer are: * To assess if proactive therapy can effectively trea...
Detailed Description
This is a blinded, randomised, crossover, study on patients diagnosed with obstructive sleep apnea who regularly adhere to APAP therapy. Data collection will span 23 consecutive nights for each partic...
Eligibility Criteria
Inclusion
- Must be a current CPAP user
- Must have used a PAP device for more than 4 months.
- Before the first night of the study, participant must be willing to lend their personal PAP device for inspection in order for the study coordinator to transfer their PAP therapy settings to one of our modified PAP devices.
- Must be willing to wear the sleep diagnostic ring throughout each night of the study for the entire study duration (i.e., the full 23 days).
- Must be willing to have their CPAP SD memory card analyzed to determine their mean pressure and excess leak rate history
- Must be free of flu-like illness or any upper tract infection symptoms at the time of data collection.
Exclusion
- Subjects actively using bi-level PAP or require oxygen therapy.
- Inspection of the participant's CPAP SD card data shows that history of highly frequent excess leak during therapy. Exclusion due to high leak will be determined on a case-by-case basis.
- History of severe cardiovascular disease, including NYHA Class III or IV heart failure, CAD with angina, or MI/stroke within past 6 months.
- 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 of individual 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 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.
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06144892
Start Date
March 25 2024
End Date
July 1 2024
Last Update
March 7 2024
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