The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.
Sleep Medicine and Research Center at St. Luke's Hospital
Chesterfield, Missouri, United States
Week 1 AHI as compared to Screening/Baseline AHI
Time frame: 1 week
Week 5 AHI as compared to Screening/Baseline AHI
Time frame: 5 weeks
Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline
Time frame: 5 weeks
Epworth Sleepiness Scale: Week 5 vs. Baseline
Time frame: 5 weeks
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