Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Higher levels of CPAP are associated with higher leak. In the present study, a sequential approach to control excessive unintentional leak will be tested. In study A, the reduction of therapeutic CPAP level will be tested. In study B, oronasal CPAP will be compared to nasal CPAP with a chinstrap.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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 drops of leak over one night of nasal CPAP

• Persistence of excessive leak at the end of Study A.

Locations
Other Locations
Brazil
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Pedro Genta
prgenta@gmail.com
551126625486
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Oronasal CPAP
CPAP with an oronasal mask for 7 days.
Experimental: Chinstrap
CPAP with a nasal mask and a chinstrap for 7 days.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital

This content was sourced from clinicaltrials.gov