Sleep Apnea, ObstructiveObesAOSNCT07001215
Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol
A study testing In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours. and CPAP in people with Sleep Apnea, Obstructive and Bariatric Surgery, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Bariatric Surgery, Obesity
- What is being tested?
- In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours. and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2025to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aldara García-Sánchez, PhD Pneumology Consultant contact
Spain1 site
Hospital Universitario Ramón y Cajal,
Madrid, Spain, 28034
Laura Pozuelo-Sánchez, Nurse, 913368000 ext. 489059, utrs.ryc@gmail.com
About this study
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.
Read more
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)
- Being tested
- In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours., CPAP
- Keywords
- Obstructive Sleep Apnea (OSA), Continuous Positive Airway Pressure (CPAP), Automatic Positive Airway Pressure (APAP), Bariatric Surgery, Obesity
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours.Device
Also called APAP, Automatic Positive Airway Pressure
AutoCPAP will be prescribed to patients undergoing bariatric surgery.
CPAPDevice
Also called Continuous Positive Airway Pressure
In the control group, patients will be treated with CPAP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.
Reduction in Residual AHI
To evaluate the reduction in the residual Apnea-Hypopnea Index (AHI) in both groups. Unit of Measure: Residual AHI (events per hour).
Measured: 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).
Measured: 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).
Measured: (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).
Measured: 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).
Measured: (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).
Measured: (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.
Measured: 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.
Measured: (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.
Measured: (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.
Measured: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, parallel-group, open-label, controlled clinical trial.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Responsible party
- Principal investigator, Laura Pozuelo Sánchez, Hospital Universitario Ramon y Cajal
- Investigators
- Laura Pozuelo-Sánchez, Nurse, Principal investigator, Iricys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001215
- Sponsor's protocol ID
- 111/25
- Acronym
- ObesAOS
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33547713Katasani 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.
PubMed 37140722Collen 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.
PubMed 25515283de 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.
PubMed 29176373Joosten 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.
PubMed 28185772Kapur 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.
PubMed 28162150Xu 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.
PubMed 38806646Mediano 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.
PubMed 33875282Young 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.
PubMed 8464434
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP Versus APAP in Patients With Obesity Undergoing Bariatric Surgery Protocol
- ClinicalTrials.gov ID
- NCT07001215
- Acronym / sponsor ID
- ObesAOS / 111/25
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, parallel-group, open-label, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| APAP Group | Experimental | Device: In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours.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. |
| CPAP group | Active comparator | Device: CPAPCPAP 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours.Also: APAP, Automatic Positive Airway PressureAutoCPAP will be prescribed to patients undergoing bariatric surgery. | Device | APAP Group |
| CPAPAlso: Continuous Positive Airway PressureIn the control group, patients will be treated with CPAP. | Device | CPAP group |
Primary outcome
APAP vs. CPAP: Impact on Nightly Usage in Obese Patients Undergoing Bariatric Surgery
Time frame: 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.
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).
11 secondary outcomes
Therapy Adherence Over Time
Time frame: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.
Reduction in Residual AHI
Time frame: 3 months before bariatric surgery and at 3, 6, and 12 months postoperatively.
Daytime Sleepiness
Time frame: 3, 6, and 12 months postoperatively
Pressure Requirement Trends
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Pressure Adaptability of APAP
Time frame: 3, 6, and 12 months postoperatively
Side Effects Monitoring
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Sleep Quality (assessed using the Pittsburgh Sleep Quality Index)
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
General Quality of Life (assessed using the EuroQol-5D)
Time frame: 3 months pre-surgery and 3, 6, and 12 months postoperatively.
Reduction in Outpatient Visits
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Healthcare Resource Optimization
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
STOP-BANG Questionnaire Accuracy
Time frame: (3 months pre-surgery and 3, 6, and 12 months postoperatively).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 33547713Kermelly 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.
- Background: PubMed 37140722Katasani 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.
- Background: PubMed 25515283Collen 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.
- Background: PubMed 29176373de 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.
- Background: PubMed 28185772Joosten 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.
- Background: PubMed 28162150Kapur 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.
- Background: PubMed 38806646Xu 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.
- Background: PubMed 33875282Mediano 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.
- Background: PubMed 8464434Young 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aldara García-Sánchez, PhD Pneumology Consultant contact
Laura Pozuelo-Sánchez, Nurse principal investigator
Iricys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In the intervention group, patients will be treated with auto-adjusting APAP, providing variable pressures throughout the sleep hours. and CPAP in people with Sleep Apnea, Obstructive and Bariatric Surgery, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Pozuelo- Sánchez, Nurse (913368000 ext. 489059, utrs.ryc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APAP vs. CPAP: Impact on Nightly Usage in Obese Patients Undergoing Bariatric Surgery (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001215, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.