PHOEBIBreathing Changes in Obesity and Effects of Bariatric Surgery
This observational study aims to explore how the degree of change in breathing patterns, specifically expiratory flow limitation, can differentiate between individuals with obesity who have normal carbon dioxide levels (eucapnic) and those with high carbon dioxide levels (hypercapnic), as well as the impact of bariatric surgery on these changes.
Data Collection
Collected from today forward - ProspectiveApnea+14
+ Hypoventilation
+ Nervous System Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: June 20, 2019
Actual date on which the first participant was enrolled.Obesity can affect how a person breathes, leading to issues like sleep disordered breathing, a condition where breathing is abnormal during sleep, the most common form being obstructive sleep apnoea. If these breathing problems worsen, they can cause a rise in carbon dioxide levels during the day, leading to a condition called obesity hypoventilation syndrome (OHS). Current treatments include supportive breathing therapy at night, managing associated medical conditions, and weight loss. This study focuses on understanding how these breathing changes occur due to obesity and how they might improve after weight loss surgery. It specifically looks at individuals with sleep disordered breathing who are waiting for bariatric surgery, comparing those with OHS to those with normal carbon dioxide regulation. Participants in this study will be recruited from outpatient clinics for sleep disordered breathing. They will undergo comprehensive breathing assessments upon enrollment, including an overnight sleep study. Further daytime breathing assessments will be conducted before and after their bariatric surgery. The study will end 6 months after surgery, with a final comprehensive breathing assessment and overnight sleep study to review any improvements in their breathing. The primary outcomes of the study include measuring changes in expiratory flow limitation, which is the difficulty in exhaling air, at different positions. The study will explore whether these changes can differentiate between patients with normal and high carbon dioxide levels.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Guy's and St Thomas' NHS Trust
London, United KingdomOpen Guy's and St Thomas' NHS Trust in Google Maps