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Search / Trial NCT07001215

Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol

Launched by HOSPITAL UNIVERSITARIO RAMON Y CAJAL · May 22, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Obstructive Sleep Apnea (Osa) Continuous Positive Airway Pressure (Cpap) Automatic Positive Airway Pressure (Apap) Bariatric Surgery Obesity

ClinConnect Summary

This clinical trial is studying the effects of two types of sleep apnea treatments, Continuous Positive Airway Pressure (CPAP) and Automatic Positive Airway Pressure (APAP), in obese patients who are getting bariatric surgery. The goal is to see which treatment helps patients use their therapy more consistently and improves their sleep quality after surgery. Sleep apnea is a condition where a person's breathing is interrupted during sleep, and it can be especially common in people with obesity. The trial will look at how well patients stick to their treatment, how their sleep apnea symptoms change, and how their overall quality of life improves over a year.

To participate in this study, you need to be between 18 to 80 years old, have a body mass index (BMI) of 30 or higher, and have a diagnosis of moderate to severe sleep apnea. You also need to be on the waiting list for bariatric surgery and able to understand and sign the consent form. If you join the trial, you will be randomly assigned to either the CPAP or APAP treatment, and you'll have follow-up visits at 3, 6, and 12 months after your surgery to check your progress. This study aims to find out which treatment works better for patients like you, ultimately helping to improve sleep apnea care and reduce the need for extra doctor's visits.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Hospital Universitario Ramon Y Cajal

Hospital Universitario Ramón y Cajal, located in Madrid, Spain, is a leading academic medical center recognized for its commitment to innovative research and high-quality patient care. As a prominent institution affiliated with the University of Alcalá, it combines clinical excellence with a robust research agenda, fostering advancements in medical science through rigorous clinical trials. The hospital is dedicated to enhancing patient outcomes and contributing to the global medical community by exploring new therapeutic approaches and healthcare solutions across various specialties.

Locations

Madrid, , Spain

Patients applied

0 patients applied

Trial Officials

Laura Pozuelo-Sánchez, Nurse

Principal Investigator

Iricys

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported