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

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 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.

Conditions

• Sleep Apnea, Obstructive
• Bariatric Surgery
• Obesity
• Treatment Adherence and Compliance
• Continuous Positive Airway Pressure (CPAP)

Interventions

DEVICE

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

AutoCPAP will be prescribed to patients undergoing bariatric surgery.

DEVICE

CPAP

In the control group, patients will be treated with CPAP.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  lead OTHER

Principal Investigators

• Laura Pozuelo-Sánchez, Nurse · Iricys

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-15

Primary Completion

2027-09-15

Completion

2028-09-15

Countries

• Spain

Study Locations