- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793334
Underlying Mechanisms of Obesity-induced Obstructive Sleep Apnea (Slim-OSA)
May 28, 2024 updated by: Brandon Nokes
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Obstructive sleep apnea (OSA) is a highly prevalent disease with major neurocognitive and cardiovascular sequelae.
Obesity is a major risk factor for OSA, but the underlying mechanisms remain unclear.
Given the rising prevalence of obesity and the lack of adequate therapies for some afflicted patients, further mechanistic work is clearly required.
Bariatric surgery is being done increasingly with compelling outcome data emerging; however, clinical response to weight loss is highly variable.
In some patients, OSA is not present at baseline, despite morbid obesity, in other patients, OSA resolves following bariatric surgery, while other patients have persistence of OSA despite weight loss, and still other patients can experience re-emergence of OSA in long term follow-up studies after bariatric surgery.
OSA can occur due to several major pathophysiological factors including pharyngeal anatomy, pharyngeal dilator muscle dysfunction, unstable ventilatory control, end- expiratory lung volume and arousal threshold.
As a result considerable complexity exists in the obesity/OSA relationship, suggesting the need for further research.
First, the investigators will perform a baseline evaluation of pathophysiological traits among obese people prior to weight loss surgery.
Because some people will have OSA and some will not, the investigators will define the potential mechanisms underlying OSA and potential protective mechanisms among obese people without OSA (pharyngeal critical closing pressure Pcrit primary outcome).
Second, the investigators will re-evaluate these same individuals from the standpoint of sleep study and pathophysiological traits six months following bariatric surgery after a variable degree of weight loss.
The investigators anticipate that some OSA patients will have resolution of OSA whereas others will have persistence of disease.
For non-OSA patients undergoing weight loss, the investigators will have a positive control group which will allow the investigators to account for non-specific effects of weight loss.
This aim will allow the investigators to test the hypothesis that pharyngeal mechanics is the predominant mechanism whereby weight loss leads to improvement in OSA.
Third, the investigators will perform magnetic resonance imaging during wakefulness at functional residual capacity, total lung capacity and residual volume on participants at baseline and 6months following bariatric surgery.
This aim will allow the investigators to perform structure/function assessments in our participants, to define the impact of weight loss on pharyngeal anatomy, and to quantify the lung volume dependence of the upper airway before and after weight loss.
The acquired data will also be used for computational modeling including dynamic assessment of pharyngeal function during tidal breathing.
As a result of the proposed research, the investigators are confident that the investigators will gain major insights into the as yet unanswered question "why does obesity (sometimes) cause sleep apnea".
This research will have major therapeutic implications as it will allow the investigators to individualize therapy for afflicted patients.
Study Type
Observational
Enrollment (Estimated)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- UCSD - Altman Clinical Research Institute (ACTRI)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
Inclusion Criteria:
- - Men and women
- Ages >= 18-65 years old
- BMI 35 kg/m2--and above
- Scheduled for sleeve gastrectomy (bariatric surgery)
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obese + OSA
Inclusion Criteria:
Exclusion Criteria:
|
routine sleeve gastrectomy
|
Obese without OSA
Inclusion Criteria:
Exclusion Criteria:
|
routine sleeve gastrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle traits contributing to OSA in obesity - change is being assessed over time
Time Frame: Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery
|
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
Time Frame: Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following 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
Time Frame: Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exploratory outcomes
Time Frame: Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery
|
phlebotomy for ABG and transcriptomic assessments - change is being assessed over time
|
Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2021
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
May 31, 2026
Study Registration Dates
First Submitted
March 5, 2021
First Submitted That Met QC Criteria
March 9, 2021
First Posted (Actual)
March 11, 2021
Study Record Updates
Last Update Posted (Actual)
May 29, 2024
Last Update Submitted That Met QC Criteria
May 28, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCSD HRPP 191948
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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