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| Name | Class |
|---|---|
| Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APAP Group | Experimental | 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. |
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| CPAP group | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours. | Device | AutoCPAP will be prescribed to patients undergoing bariatric surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively. |
| Reduction in Residual AHI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Pozuelo- Sánchez, Nurse | Contact | 913368000 | 489059 | utrs.ryc@gmail.com |
| Aldara García-Sánchez, PhD Pneumology Consultant | Contact | 913368000 | 489060 | aldara.garcia.ag@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Laura Pozuelo-Sánchez, Nurse | Iricys | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal, | Madrid | Spain | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33547713 | Background | 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. | |
| 37140722 | Background | 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. |
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Single-center, randomized, parallel-group, open-label, controlled clinical trial.
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| CPAP | Device | In the control group, patients will be treated with CPAP. |
|
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To evaluate the reduction in the residual Apnea-Hypopnea Index (AHI) in both groups. Unit of Measure: Residual AHI (events per hour). |
| 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). | 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). | (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). | 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). | (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). | (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. | 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. | (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. | (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. | (3 months pre-surgery and 3, 6, and 12 months postoperatively). |
| 25515283 | Background | 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. |
| 29176373 | Background | 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. |
| 28185772 | Background | 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. |
| 28162150 | Background | 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. |
| 38806646 | Background | 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. |
| 33875282 | Background | 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 Rodrigo MB, Lecube A, Madrid JA, Maniegas Lozano L, Martinez Carrasco JL, Masa JF, Masdeu Margalef MJ, Mayos Perez M, Mirabet Lis E, Monasterio C, Navarro Soriano N, Olea de la Fuente E, Plaza G, Puertas Cuesta FJ, Rabec C, Resano P, Rigau D, Roncero A, Ruiz C, Salord N, Saltijeral A, Sampol Rubio G, Sanchez Quiroga MA, Sans Capdevila O, Teixeira C, Tinahones Madueno F, Maria Togeiro S, Troncoso Acevedo MF, Vargas Ramirez LK, Winck J, Zabala Urionaguena N, Egea C; el Spanish Sleep Network. International Consensus Document on Obstructive Sleep Apnea. Arch Bronconeumol. 2022 Jan;58(1):52-68. doi: 10.1016/j.arbres.2021.03.017. Epub 2021 Mar 24. English, Spanish. |
| 8464434 | Background | Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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