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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• APAP vs. CPAP: Impact on Nightly Usage in Obese Patients Undergoing Bariatric Surgery [Срок оценки: 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.]

Вторичные конечные точки (11)

• Therapy Adherence Over Time [Срок оценки: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.]
• Reduction in Residual AHI [Срок оценки: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.]
• Daytime Sleepiness [Срок оценки: 3, 6, and 12 months postoperatively]
• Pressure Requirement Trends [Срок оценки: (3 months pre-surgery and 3, 6, and 12 months postoperatively).]
• Pressure Adaptability of APAP [Срок оценки: 3, 6, and 12 months postoperatively]
• Side Effects Monitoring [Срок оценки: (3 months pre-surgery and 3, 6, and 12 months postoperatively).]
• Sleep Quality (assessed using the Pittsburgh Sleep Quality Index) [Срок оценки: (3 months pre-surgery and 3, 6, and 12 months postoperatively).]
• General Quality of Life (assessed using the EuroQol-5D) [Срок оценки: 3 months pre-surgery and 3, 6, and 12 months postoperatively.]
• Reduction in Outpatient Visits [Срок оценки: (3 months pre-surgery and 3, 6, and 12 months postoperatively).]
• Healthcare Resource Optimization [Срок оценки: (3 months pre-surgery and 3, 6, and 12 months postoperatively).]
• STOP-BANG Questionnaire Accuracy [Срок оценки: (3 months pre-surgery and 3, 6, and 12 months postoperatively).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario Ramón y Cajal, — Madrid

Публикации

• Kermelly SB, Lajoie AC, Boucher ME, Series F. Impact of continuous positive airway pressure mode on adherence to treatment in obstructive sleep apnea patients awaiting bariatric surgery. J Sleep Res. 2021 Oct;30(5):e13288. doi: 10.1111/jsr.13288. Epub 2021 Feb 6. PMID 33547713
• Katasani T, Holt G, Al-Khyatt W, Idris I. Peri- and Postoperative Outcomes for Obstructive Sleep Apnoea Patients after Bariatric Surgery-a Systematic Review and Meta-analysis. Obes Surg. 2023 Jul;33(7):2016-2024. doi: 10.1007/s11695-023-06557-8. Epub 2023 May 4. PMID 37140722
• Collen J, Lettieri CJ, Eliasson A. Postoperative CPAP use impacts long-term weight loss following bariatric surgery. J Clin Sleep Med. 2015 Mar 15;11(3):213-7. doi: 10.5664/jcsm.4528. PMID 25515283
• de Raaff CAL, de Vries N, van Wagensveld BA. Obstructive sleep apnea and bariatric surgical guidelines: summary and update. Curr Opin Anaesthesiol. 2018 Feb;31(1):104-109. doi: 10.1097/ACO.0000000000000542. PMID 29176373
• Joosten SA, Hamilton GS, Naughton MT. Impact of Weight Loss Management in OSA. Chest. 2017 Jul;152(1):194-203. doi: 10.1016/j.chest.2017.01.027. Epub 2017 Feb 6. PMID 28185772
• Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506. PMID 28162150
• Xu YX, Wang SS, Wan YH, Su PY, Tao FB, Sun Y. Association of sleep fragmentation with general and abdominal obesity: a population-based longitudinal study. Int J Obes (Lond). 2024 Sep;48(9):1258-1265. doi: 10.1038/s41366-024-01547-x. Epub 2024 May 28. PMID 38806646
• Mediano O, Gonzalez Mangado N, Montserrat JM, Alonso-Alvarez ML, Almendros I, Alonso-Fernandez A, Barbe F, Borsini E, Caballero-Eraso C, Cano-Pumarega I, de Carlos Villafranca F, Carmona-Bernal C, Carrillo Alduenda JL, Chiner E, Cordero Guevara JA, de Manuel L, Duran-Cantolla J, Farre R, Franceschini C, Gaig C, Garcia Ramos P, Garcia-Rio F, Garmendia O, Gomez Garcia T, Gonzalez Pondal S, Hoyo Rodr PMID 33875282

Идентификаторы

NCT: NCT07001215 · 111/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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