An interventional study of In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours. and CPAP in Sleep Apnea, Obstructive, Bariatric Surgery and Obesity, sponsored by Hospital Universitario Ramon y Cajal. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Hospital Universitario Ramon y Cajal · Not applicable, Interventional, and Treatment
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's planned enrollment of 104 is above the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Hospital Universitario Ramon y Cajal is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
APAP Group: They will receive treatment with AutoCPAP. The device automatically adjusts the air pressure according to the patient's needs, and usage data and respiratory events will be manually collected at each visit.
Device: In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours.
CPAP Group: They will receive treatment with conventional CPAP. The device will provide a fixed and constant air pressure, and follow-up will be conducted through in-person visits and titration with APAP after adherence to verify the optimal pressure. The initial CPAP pressure will be individually calculated using Hoffstein's formula based on parameters such as body mass index (BMI), neck circumference, and apnea-hypopnea index (AHI).
Device: CPAP
AutoCPAP will be prescribed to patients undergoing bariatric surgery.
Also known as: APAP, Automatic Positive Airway Pressure
In the control group, patients will be treated with CPAP.
Also known as: Continuous Positive Airway Pressure
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).
Time frame: Obese patients undergoing bariatric surgery will be evaluated during the 3 months prior to surgery and at 3, 6, and 12 months postoperatively in patients with OSA undergoing bariatric surgery.
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.
Time frame: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.
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).
Time frame: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.
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).
Time frame: 3, 6, and 12 months postoperatively
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).
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Pressure Adaptability of APAP
To assess the adaptability of APAP therapy to varying pressure requirements over time, compared to fixed-pressure CPAP, in patients with OSA following bariatric surgery. Unit of Measure: Variability in delivered pressure (cm H₂O).
Time frame: 3, 6, and 12 months postoperatively
Side Effects Monitoring
To measure and compare the presence of side effects (e.g., nasal dryness, skin irritation) in both groups. Unit of Measure: Incidence of reported side effects (percentage of patients affected).
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Sleep Quality (assessed using the Pittsburgh Sleep Quality Index)
To assess sleep quality using the validated Pittsburgh Sleep Quality Index (PSQI) questionnaire.in both groups. Unit of Measure: Total PSQI score (range: 0-21; higher scores indicate poorer sleep quality).
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
General Quality of Life (assessed using the EuroQol-5D)
To assess general quality of life using the validated EuroQol-5D (EQ-5D) questionnaire. Unit of Measure: EQ-5D Utility Index and Visual Analogue Scale (VAS) score 0-100.
Time frame: 3 months pre-surgery and 3, 6, and 12 months postoperatively.
Reduction in Outpatient Visits
To analyze the potential reduction in outpatient clinic visits in the APAP group compared to the CPAP group. Unit of Measure: Number of outpatient visits per patient.
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Healthcare Resource Optimization
To evaluate the reduction in repeated sleep studies as an indicator of healthcare resource optimization in patients treated with APAP compared to CPAP. Unit of Measure: Number of repeated sleep studies per patient.
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
STOP-BANG Questionnaire Accuracy
To assess the sensitivity and specificity of the STOP-BANG questionnaire for detecting OSA in bariatric patients, and to determine whether a new cutoff point is needed to optimize its performance in this population. Unit of Measure: STOP-BANG total score (range 0 to 8); sensitivity and specificity percentages for different cutoff points.
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Plan to share: Undecided
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Hospital Universitario Ramon y Cajal