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

NCT ID: NCT07001215

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2028-09-15

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

APAP Group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

AutoCPAP will be prescribed to patients undergoing bariatric surgery.

CPAP group

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).

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

CPAP

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

Intervention Type: DEVICE

Other Intervention Names

APAP; Automatic Positive Airway Pressure; Continuous Positive Airway Pressure

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Laura Pozuelo Sánchez

University Diploma in Nursing from UAM and Bachelor's Degree in Psychology from UNED. Biomedical researcher at IRYCIS.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Pozuelo-Sánchez, Nurse

Role: PRINCIPAL_INVESTIGATOR

Iricys

Locations

Hospital Universitario Ramón y Cajal,

Madrid, Spain, Spain

Countries

Spain

Central Contacts

Laura Pozuelo- Sánchez, Nurse

Role: CONTACT

utrs.ryc@gmail.com

913368000 ext. 489059

Aldara García-Sánchez, PhD Pneumology Consultant

Role: CONTACT

aldara.garcia.ag@gmail.com

913368000 ext. 489060

Facility Contacts

Laura Pozuelo-Sánchez, Nurse

Role: primary

utrs.ryc@gmail.com

913368000 ext. 489059

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Other Identifiers

111/25

Identifier Type: -

Identifier Source: org_study_id