Status:
COMPLETED
Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy
Lead Sponsor:
Mayo Clinic
Conditions:
Sleep Apnea, Obstructive
Obesity Hypoventilation Syndrome (OHS)
Eligibility:
All Genders
18+ years
Brief Summary
Continuous positive airway pressure and non-invasive ventilation are common treatment modalities for obstructive sleep apnea, central sleep apnea, and chronic alveolar hypoventilation from a variety o...
Detailed Description
Patients will be recruited from Mayo Clinic sleep medicine practices who have completed testing and are initiating PAP therapy for obstructive sleep apnea (OSA), obesity hypoventilation syndrome (OHS)...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- Sleep testing shows an apnea-hypopnea index or respiratory event index ≥5
- Patient is PAP naïve or no PAP use within the last 10 years
- Patient's diagnosis is obstructive sleep apnea, obesity hypoventilation syndrome, or central sleep apnea syndrome
- Prescribed therapy is CPAP, A-PAP, or BPAP in a spontaneous modality
- Patient is able to provide consent
- Patient is English speaking (limited to English for device)
Exclusion
- Prescribed therapy is BPAP ST or ASV
- Patient is not able to provide consent
- Patient is not able to speak or read English
- Nasal or facial trauma or surgery that leaves atypical facial features
Key Trial Info
Start Date :
June 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04688125
Start Date
June 17 2021
End Date
December 31 2024
Last Update
February 28 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905