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.
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.
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
Parallel
In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours.
DeviceAutoCPAP will be prescribed to patients undergoing bariatric surgery.
CPAP
DeviceIn the control group, patients will be treated with CPAP.
APAP vs. CPAP: Impact on Nightly Usage in Obese Patients Undergoing Bariatric Surgery
To determine whether APAP therapy increases nightly usage hours compared to CPAP therapy in obese patients undergoing bariatric surgery. Unit of Measure: Average hours of PAP use per night (measured via device data).
Therapy Adherence Over Time
To measure and compare the percentage of nights with therapy usage exceeding 4 hours in both groups (APAP and fixed CPAP). Unit of Measure: Percentage of nights with ≥4 hours of PAP use.
Reduction in Residual AHI
To evaluate the reduction in the residual Apnea-Hypopnea Index (AHI) in both groups. Unit of Measure: Residual AHI (events per hour).
Daytime Sleepiness
To assess changes in daytime sleepiness using validated scales (e.g., Epworth Sleepiness Scale) in both groups. Unit of Measure: Total ESS score (range: 0-24; higher scores indicate greater sleepiness).
Pressure Requirement Trends
To evaluate and compare changes in positive airway pressure (PAP) requirements, measured in cm H₂O, in patients treated with APAP or CPAP over time. Unit of Measure: Pressure level (cm H₂O).
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Hospital Universitario Ramon y Cajal
Lead sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborator
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