Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- APAP vs. CPAP: Impact on Nightly Usage in Obese Patients Undergoing Bariatric Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
APAP vs. CPAP: Impact on Nightly Usage in Obese Patients Undergoing Bariatric Surgery
时间窗: 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.
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).
APAP vs. CPAP: Impact on Nightly Usage in Obese Patients Undergoing Bariatric Surgery
时间窗: 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.
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).
次要结局
- Therapy Adherence Over Time(3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.)
- Reduction in Residual AHI(3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.)
- Daytime Sleepiness(3, 6, and 12 months postoperatively)
- Pressure Requirement Trends((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- Pressure Adaptability of APAP(3, 6, and 12 months postoperatively)
- Reduction in Outpatient Visits((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- Healthcare Resource Optimization((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- STOP-BANG Questionnaire Accuracy((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- Pressure Adaptability of APAP(3, 6, and 12 months postoperatively)
- Side Effects Monitoring((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- Sleep Quality (assessed using the Pittsburgh Sleep Quality Index)((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- Therapy Adherence Over Time(3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.)
- Reduction in Residual AHI(3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.)
- Daytime Sleepiness(3, 6, and 12 months postoperatively)
- Pressure Requirement Trends((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- General Quality of Life (assessed using the EuroQol-5D)(3 months pre-surgery and 3, 6, and 12 months postoperatively.)
- Reduction in Outpatient Visits((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- Healthcare Resource Optimization((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
- STOP-BANG Questionnaire Accuracy((3 months pre-surgery and 3, 6, and 12 months postoperatively).)
研究者
Laura Pozuelo Sánchez
University Diploma in Nursing from UAM and Bachelor's Degree in Psychology from UNED. Biomedical researcher at IRYCIS.
Hospital Universitario Ramon y Cajal