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

NCT07001215 | Not Yet Recruiting DMC

• 1 other identifier: 111/25
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive; Bariatric Surgery; Obesity; Treatment Adherence and Compliance; Continuous Positive Airway Pressure (CPAP)

Keywords

Obstructive Sleep Apnea (OSA); Continuous Positive Airway Pressure (CPAP); Automatic Positive Airway Pressure (APAP); Bariatric Surgery; Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (11)

• 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

Study Arms (2)

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.

Device: In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours.

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).

Device: CPAP

Interventions

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.

Also known as: APAP, Automatic Positive Airway Pressure

APAP Group

CPAP DEVICE

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

Also known as: Continuous Positive Airway Pressure

CPAP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead
• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: collaborator

Study Sites (1)

Hospital Universitario Ramón y Cajal,

Madrid, Spain, 28034, Spain

Location

Related Publications (9)

• 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 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.

  PMID: 37140722 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.

  PMID: 25515283 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.

  PMID: 29176373 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.

  PMID: 28185772 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.

  PMID: 28162150 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.

  PMID: 38806646 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.

  PMID: 33875282 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.

  PMID: 8464434 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity; Treatment Adherence and Compliance

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Laura Pozuelo-Sánchez, Nurse

  Iricys

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Pozuelo- Sánchez, Nurse

CONTACT

913368000; utrs.ryc@gmail.com

Aldara García-Sánchez, PhD Pneumology Consultant

CONTACT

913368000; aldara.garcia.ag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Diploma in Nursing from UAM and Bachelor's Degree in Psychology from UNED. Biomedical researcher at IRYCIS.

Model Details: Single-center, randomized, parallel-group, open-label, controlled clinical trial.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 3, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2028
• Last Updated: July 23, 2025

Record last verified: 2025-05

Locations

ES (1)