Status:
ACTIVE_NOT_RECRUITING
Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Expiratory pressure relief (EPR) is a technology designed to improve patient comfort during continous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). The investigators hyp...
Detailed Description
Participants will be recruited at the sleep clinic. The study will be carried out in 4 steps, the first 2 during one night of full polysomnography (PSG) and the last 2 during CPAP treatment for 4 week...
Eligibility Criteria
Inclusion
- both sexes
- aged eighteen or over
- already have baseline polysomnography showing a severe Apnea-Hypopnea Index (AIH), defined according to the current criteria of the American Academy of Sleep Medicine (AASM) as 30 events / hour of sleep or more
- already be using a continuous positive pressure device (CPAP) at a pressure equal to or greater than 9 cmH2O with good adherence, defined as an average use equal to or greater than 4 hours per day.
Exclusion
- Patients with:
- severe or decompensated respiratory or cardiac diseases
- previous pharyngeal surgery or other sleep disorders, such as parasomnias, narcolepsy or primary insomnia
- users of sedative medications such as opioids, benzodiazepines and muscle relaxants
- uncontrolled diabetes or hyperthyroidism
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05219591
Start Date
January 1 2022
End Date
December 1 2024
Last Update
February 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, 55