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Transdisciplinary Intervention for Obesity Hypoventilation Syndrome

NCT07020689 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2025-06-13

No results posted yet for this study

Summary

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.

Conditions

  • Obesity Hypoventilation Syndrome (OHS)
  • Obstructive Sleep Apnea (OSA)

Interventions

PROCEDURE

CABS

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Hsueh-Yu Li, M.D. · Chang Gung Memorial Hospital

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-08-31
Completion
2024-11-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020689 on ClinicalTrials.gov