Department of ENT, Linkou Chang Gung Memorial Hospital
Taoyuan City, 33305, Taiwan
NCT Number: NCT07020689
The aims of this prospective observational cohort study are threefold: (1) to assess the prevalence of obesity hypoventilation syndrome (OHS) in individuals with obesity and obstructive sleep apnea (OSA) and identify associated risk factors, (2) to determine clinical predictors of OHS, and (3) to evaluate the therapeutic outcomes of combined airway and bariatric surgery (CABS) in this population.
Looking for future studies?
Notify Me20 year–65 year
All sexes
Observational
Taoyuan City, 33305, Taiwan
This study was approved by the Institutional Review Board of Chang Gung Medical Foundation on August 8, 2022 (IRB No. 202201000A3). Written informed consent was obtained from all participants. All procedures adhered to the principles outlined in the Declaration of Helsinki and were reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROCSS) guidelines.
This was a two-year prospective observational cohort study conducted at the tertiary referral sleep center of Linkou Chang Gung Memorial Hospital from December 1, 2022, to November 30, 2024. Obesity hypoventilation syndrome (OHS) was diagnosed based on the presence of BMI ≥ 30 kg/m², PaCO₂ ≥ 45 mmHg on arterial blood gas (ABG) analysis, and sleep-disordered breathing, following the exclusion of other potential causes of alveolar hypoventilation using pulmonary function tests.
Adults aged 20 to 65 years were eligible if they met the following inclusion criteria: (1) BMI ≥ 30 kg/m², and (2) AHI ≥ 5 events/hour. Individuals were excluded if they had (1) persistent decompensated hypercapnic respiratory failure (arterial pH < 7.3), (2) acute respiratory failure requiring invasive mechanical ventilation, (3) significant neuromuscular disease, chest wall deformities, or pulmonary disease contributing to hypoventilation, (4) unstable coronary artery disease, or (5) cognitive impairment precluding informed consent or protocol adherence.
Following diagnosis, individuals with OHS were counseled on therapeutic options, including continuous positive airway pressure (CPAP) therapy, body weight reduction, or combined airway and bariatric surgery (CABS). The final decision was made through a shared decision-making process.
Outcome measures included (1) Polysomnography: All participants underwent attended level I polysomnography using the Nicolet UltraSom System (Nicolet, Madison, WI). AHI was the primary sleep parameter, defined as the total number of apneas (≥ 90% airflow reduction for ≥10 seconds) and hypopneas (> 50% airflow reduction with ≥ 3% oxygen desaturation or arousal) per hour of sleep. Scoring was performed by a single blinded sleep specialist. (2) Pulmonary function testing: Spirometry was performed using a handheld spirometer in accordance with international guidelines. Parameters included forced vital capacity (FVC), forced expiratory volume in 1 second (FEV₁), and FEV₁/FVC ratio. (3) Gas exchange: ABG analysis was conducted during daytime hours with the participant seated and breathing room air after resting for at least 60 minutes. (4) Epworth sleepiness scale: Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS), a validated 8-item questionnaire with total scores ranging from 0 to 24; higher scores indicate greater daytime sleepiness.
The prevalence of OHS was calculated as the proportion of individuals diagnosed with OHS among those with concurrent obesity and obstructive sleep apnea (OSA). A multivariate logistic regression analysis with forward selection was conducted to identify independent predictors of OHS. Receiver operating characteristic (ROC) curve analysis was used to determine the optimal cut-off points for various predictors. To evaluate the effects of the CABS intervention, pre- and post-operative changes in clinical parameters were compared.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(1) BMI ≥ 30 kg/m², and (2) AHI ≥ 5 events/hour.
Exclusion criteria
(1) persistent decompensated hypercapnic respiratory failure (arterial pH < 7.3), (2) acute respiratory failure requiring invasive mechanical ventilation, (3) significant neuromuscular disease, chest wall deformities, or pulmonary disease contributing to hypoventilation, (4) unstable coronary artery disease, or (5) cognitive impairment precluding informed consent or protocol adherence.
Following diagnosis, individuals with OHS were counseled on therapeutic options, including CPAP therapy, body weight reduction, or CABS. The final decision was made through a shared decision-making process. The CABS procedure was conducted under general anesthesia and integrated bariatric and multilevel airway surgery within a single operative session. This transdisciplinary approach aimed to address both sleep-disordered breathing and obesity-related ventilatory compromise. A general surgeon performed the bariatric procedure, while an otorhinolaryngologist conducted the airway surgery sequentially during the same operation. For the bariatric component, laparoscopic sleeve gastrectomy (LSG) was the primary procedure, while laparoscopic Roux-en-Y gastric bypass was reserved for individuals with significant gastroesophageal reflux or poorly controlled diabetes. Airway surgery encompassed interventions at the nasal, palatal, and lingual levels.
Time frame: From enrollment to the end of treatment at 12 months.
All participants underwent attended level I polysomnography using the Nicolet UltraSom System (Nicolet, Madison, WI). Apnea-hypopnea index (AHI) was the primary sleep parameter, defined as the total number of apneas (≥ 90% airflow reduction for ≥10 seconds) and hypopneas (> 50% airflow reduction with ≥ 3% oxygen desaturation or arousal) per hour of sleep. Scoring was performed by a single blinded sleep specialist.
Time frame: From enrollment to the end of treatment at 12 months.
Spirometry was performed using a handheld spirometer in accordance with international guidelines. Parameters included forced vital capacity (FVC), forced expiratory volume in 1 second (FEV₁), and FEV₁/FVC ratio.
Time frame: From enrollment to the end of treatment at 12 months
Arterial blood gas (ABG) analysis was conducted during daytime hours with the participant seated and breathing room air after resting for at least 60 minutes.
Time frame: From enrollment to the end of treatment at 12 months.
Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS), a validated 8-item questionnaire with total scores ranging from 0 to 24; higher scores indicate greater daytime sleepiness.
Chang Gung Memorial Hospital
Other
Combined Airway & Bariatric Surgery (CABS) for Obesity Hypoventilation Syndrome
Acronym: CABS for OHS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06560411
Apnea, Chronic Disease
Scottsdale, Arizona, United States
View Trial DetailsNCT04688125
Apnea, Dyssomnias
Rochester, Minnesota, United States
View Trial DetailsNCT04570540
Apnea, Dyssomnias
Solingen, North Rhine-Westphalia, Germany
View Trial DetailsNCT07060079
Apnea, Asthma
London, United Kingdom
View Trial Details