NCT07001215: ObesAOS

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

Not yet recruiting NA Last updated 23 July 2025

What this trial tests

NA trial testing In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours. in Sleep Apnea, Obstructive in 104 participants. Not yet recruiting.

Timeline

15 September 2025

Primary endpoint
15 September 2027

15 September 2028

Quick facts

Lead sponsor	Hospital Universitario Ramon y Cajal
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	104
Start date	15 September 2025
Primary completion	15 September 2027
Estimated completion	15 September 2028
Sites	1 location across Spain

Drugs / interventions tested

• In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours.
• CPAP

Conditions studied

• Sleep Apnea, Obstructive — all drugs for Sleep Apnea, Obstructive →
• Bariatric Surgery — all drugs for Bariatric Surgery →
• Obesity — all drugs for Obesity →
• Treatment Adherence and Compliance — all drugs for Treatment Adherence and Compliance →

Sponsor

Hospital Universitario Ramon y Cajal

Who can join

Adults 18 to 80, any sex, with Sleep Apnea, Obstructive or Bariatric Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 to intermittent hypoxia and sleep fragmentation. Obesity and OSA are closely related conditions that can exacerbate each other. Positive airway pressure therapy is essential for managing OSA, but adherence to therapy can be challenging, particularly in patients who experience rapid physiological changes after bariatric surgery.

Objective This study aims to determine whether automatic positive airway pressure therapy (APAP) improves nightly usage hours compared to continuous positive airway pressure therapy (CPAP) in obese patients undergoing bariatric surgery. Secondary objectives include evaluating the percentage of nights with therapy use over 4 hours, reduction of the residual apnea-hypopnea index (AHI), changes in daytime sleepiness, pressure requirements, side effects, sleep-related quality of life, reduction in in-person visits, and optimization of healthcare resources.

Methodology A randomized, parallel-group, open-label, controlled clinical trial will be conducted. Adult patients eligible for bariatric surgery with a diagnosis of moderate to severe OSA (AHI \> 15) requiring positive pressure therapy will be included. Participants will be randomized to receive either APAP or CPAP. Follow-up will be conducted over 12 months after surgery, with assessments at 3, 6, and 12 months. Data will be collected on treatment adherence, residual AHI, OSA symptoms, daytime sleepiness, quality of life, and treatment costs.

APAP therapy is expected to improve nightly usage hours compared to CPAP. It is also expected that APAP will show better adaptation to changing pressure needs after bariatric surgery. Data will be analyzed to evaluate the effectiveness and cost-efficiency of both therapies.

This study will provide evidence on the efficacy of APAP compared to CPAP in obese patients undergoing bariatric surgery. The results will help optimize the treatment of OSA in this population and improve patients' quality of life. Additionally, the study is expected to contribute to the optimization of healthcare resources by reducing in-person visits and repeated sleep studies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.