Last updated 3 months ago
Addressing Unintentional Leakage When Using Nasal CPAP - Study A
100 patients around the world
Available in Brazil
Study A will consist of a cross-over controlled randomized trial to compare unintentional
leak during auto-CPAP and during fixed CPAP after the progressive reduction of fixed
CPAP, starting at the 90 th percentile obtained during a period of auto-CPAP. The order
of interventions will be randomized. Auto-CPAP with a nasal mask will be used for 7 days.
In the fixed CPAP arm, CPAP will be progressively reduced over a period of up to 21 days
until leak is controlled or residual apnea-hypopnea index increases over 10 events/h.
Subjects that persisted with excessive leak at the end of the Study A will be invited to
Study B.
University of Sao Paulo General Hospital
1Research sites
100Patients around the world
This study is for people with
Sleep disorders
Sleep apnea
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Diagnosis of moderate and severe obstructive sleep apnea.Use of CPAP with a nasal mask.95th percentile of unintentional leak from the last 7 days above 24 l/min or at least 4 sudden leak line drop events.
- Patients who experience unintentional leakage from the mask/accessories.Diagnostic polysomnography examination with a predominance of central apnea.Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD.Previous surgery for obstructive sleep apnea.Severe nasal obstruction (NOSE questionnaire score equal or greater than 55 points).
Sites
Instituto do Coração do HCFMUSP
SponsorUniversity of Sao Paulo General Hospital
Conditions
Sleep apnea
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06570616
