Underlying Mechanisms of Obesity-induced Obstructive Sleep Apnea

NCT04793334 | Completed DMC

• 1 other identifier: UCSD HRPP 191948
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a common risk factor for the development of obstructive sleep apnea. However, not all subjects with obesity develop obstructive sleep apnea. This study will attempt to determine the mechanistic drivers between obesity and obstructive sleep apnea.

Conditions

Obstructive Sleep Apnea; Obesity

Outcome Measures

Primary Outcomes (3)

• muscle traits contributing to OSA in obesity - change is being assessed over time

  1\. To measure upper airway collapsibility as well as the other traits (e.g. muscle responsiveness) in both groups. The traits can be measured during sleep using our well-validated research method that mimics transient upper airway obstruction and importantly, assesses the individual's response to hypoventilation

  Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery

• changes in pcrit after bariatric surgery

  2\. We will reassess obese people with and without OSA following major weight loss (bariatric surgery). This aim will allow us to test the hypothesis that patients who experience improvement in OSA will be those with the greatest improvement in upper airway mechanics (Pcrit). The obese people without OSA undergoing weight loss will be a positive control group, which will allow us to exclude non-specific effects of weight loss.

  Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery

• MRI upper airway changes following bariatric surgery - change is being assessed over time

  3\. To determine the anatomic correlates of upper airway collapsibility in both groups using magnetic resonance imaging during natural sleep.

  Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery

Secondary Outcomes (1)

• exploratory outcomes

  Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery

Study Arms (2)

Obese + OSA

Inclusion Criteria: * Men and women * Ages \>= 18-65 years old * BMI 35 kg/m2-above * Scheduled for sleeve gastrectomy (bariatric surgery) * OSA identified by PSG Exclusion Criteria: * Any cardiovascular, pulmonary or renal disease other than well-controlled hypertension or asthma. * Pregnancy * Currently smoking * Any respiratory disorder other than OSA or well controlled asthma * contraindication to MRI

Procedure: sleeve gastectomy

Obese without OSA

Inclusion Criteria: * Men and women * Ages \>= 18-65 years old * BMI 35kg/m2 and above * Scheduled for sleeve gastrectomy (bariatric surgery) * No OSA identified by PSG Exclusion Criteria: * Any cardiovascular, pulmonary or renal disease other than well-controlled hypertension or asthma. * Pregnancy * Currently smoking * Any respiratory disorder other than OSA or well controlled asthma * contraindication to MRI

Procedure: sleeve gastectomy

Interventions

sleeve gastectomy PROCEDURE

routine sleeve gastrectomy

Obese + OSA; Obese without OSA

Eligibility Criteria

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

Study Population

Noting the inclusion and exclusion criteria above, we aim to recruit 110 patients, anticipating 20% drop out and a final n of 90. Further, we aim for to recruit 60 participants with OSA and 30 participants without OSA.

You may qualify if:

• \- Men and women
• Ages \>= 18-65 years old
• BMI 35 kg/m2--and above
• Scheduled for sleeve gastrectomy (bariatric surgery)

You may not qualify if:

• Any cardiovascular, pulmonary or renal disease other than well-controlled hypertension or asthma.
• Pregnancy
• Currently smoking
• Any respiratory disorder other than OSA or well controlled asthma
• contraindication to MRI

Sponsors & Collaborators

• Brandon Nokes: lead

Study Sites (1)

UCSD - Altman Clinical Research Institute (ACTRI)

La Jolla, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Routine phlebotomy for blood gas analysis and exploratory biomarker assessment

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post-doctoral fellow, Division of Pulmonary, Critical Care, Sleep Medicine, and Physiology

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 11, 2021
• Study Start: March 20, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)