Clinical trial NCT07001215: Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol
Official title: Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
First posted: 2025-06-03
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, randomized, parallel-group, open-label, controlled clinical trial.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: APAP vs. CPAP: Impact on Nightly Usage in Obese Patients Undergoing Bariatric Surgery
timeFrame: 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:
measure: Therapy Adherence Over Time
timeFrame: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.
measure: Reduction in Residual AHI
timeFrame: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.
measure: Daytime Sleepiness
timeFrame: 3, 6, and 12 months postoperatively
measure: Pressure Requirement Trends
timeFrame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
measure: Pressure Adaptability of APAP
timeFrame: 3, 6, and 12 months postoperatively
measure: Side Effects Monitoring
timeFrame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
measure: Sleep-Related Quality of Life
timeFrame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
measure: Reduction in Outpatient Visits
timeFrame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
measure: Healthcare Resource Optimization
timeFrame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
measure: STOP-BANG Questionnaire Accuracy
timeFrame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal,
Study officials:
affiliation: Iricys
name: Laura Pozuelo-Sánchez, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
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