Status:
NOT_YET_RECRUITING
Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol
Lead Sponsor:
Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions:
Sleep Apnea, Obstructive
Bariatric Surgery
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Introduction Obstructive sleep apnea (OSA) is a common disorder in obese patients, especially those undergoing bariatric surgery. OSA is characterized by upper airway obstruction during sleep, leading...
Eligibility Criteria
Inclusion
- Subjects aged 18 to 80 years who meet the criteria for bariatric surgery and are on the surgical waiting list after approval by the bariatric surgery committee (BMI ≥35, or BMI ≥30 with comorbidities).
- Diagnosis of moderate or severe sleep apnea, defined by an Apnea-Hypopnea Index (AHI) \>15, requiring treatment according to protocol ("Patients with an AHI of 15 or higher will be treated with CPAP if they have hypertension, excessive daytime sleepiness, or sleep-related symptoms not explained by other causes" \[17\]).
- Patients must be able to read and understand the informed consent and provide signed consent.
Exclusion
- Patients with central sleep apnea or periodic breathing
- Patients with any active neoplasm
- Patients with severe uncontrolled psychiatric disorders, alcoholism, or active drug addiction
- Patients with unacceptable surgical/anesthetic risk
- Patients who have undergone previous surgery for OSA or who have been treated with positive airway pressure and did not tolerate it
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2028
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT07001215
Start Date
September 15 2025
End Date
September 15 2028
Last Update
July 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Ramón y Cajal,
Madrid, Spain, Spain, 28034