Transdisciplinary Intervention for Obesity Hypoventilation Syndrome

NCT07020689 | Completed

• 2 other identifiers: 202201000A3CMRPG1M0101 and CMRPG1M0102
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Combined airway and bariatric surgery; Daytime hypercapnia; Obesity hypoventilation syndrome; Obstructive sleep apnea; Sleepiness; Transdisciplinary intervention

Outcome Measures

Primary Outcomes (1)

• AHI

  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.

  From enrollment to the end of treatment at 12 months.

Secondary Outcomes (3)

• FEV₁/FVC ratio

  From enrollment to the end of treatment at 12 months.

• PaCO₂

  From enrollment to the end of treatment at 12 months

• ESS score

  From enrollment to the end of treatment at 12 months.

Study Arms (1)

Obesity with OSA or OHS

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. OSA was diagnosed by standard polysomnography. 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.

Procedure: CABS

Interventions

CABS PROCEDURE

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.

Obesity with OSA or OHS

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolled consecutive patients with obesity and OSA at the tertiary referral sleep center of Linkou Chang Gung Memorial Hospital from September 1, 2022, to August 31, 2024. OHS was diagnosed based on the presence of BMI ≥ 30 kg/m², PaCO₂ ≥ 45 mmHg on ABG analysis, and sleep-disordered breathing, following the exclusion of other potential causes of alveolar hypoventilation using pulmonary function tests.

You may qualify if:

• (1) BMI ≥ 30 kg/m², and (2) AHI ≥ 5 events/hour.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of ENT, Linkou Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Location

Related Publications (1)

• Baird K, Comis LE, Joe GO, Steinberg SM, Hakim FT, Rose JJ, Mitchell SA, Pavletic SZ, Figg WD, Yao L, Flanders KC, Takebe N, Sarantopoulos S, Booher S, Cowen EW. Imatinib mesylate for the treatment of steroid-refractory sclerotic-type cutaneous chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2015 Jun;21(6):1083-90. doi: 10.1016/j.bbmt.2015.03.006. Epub 2015 Mar 12.

  PMID: 25771402 DERIVED

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Sleep Apnea, Obstructive; Sleepiness

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hsueh-Yu Li, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: September 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: June 13, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)