CPAP Impact on Glucose Metabolism in Non-Diabetic, Moderate-Severe OSA Patients
This study aims to evaluate how using a CPAP machine affects the average 24-hour glucose levels in non-diabetic individuals with moderate to severe obstructive sleep apnea.
CPAP
Apnea+11
+ Hyperglycemia
+ Metabolic Diseases
Treatment Study
Summary
Study start date: July 1, 2025
Actual date on which the first participant was enrolled.This study focuses on understanding how CPAP therapy affects glucose metabolism in individuals recently diagnosed with moderate-severe obstructive sleep apnea (OSA), but who do not have diabetes. The goal is to see if CPAP can help manage glucose levels, potentially benefiting those at risk for diabetes. The study involves people who have not yet started using CPAP therapy. During the study, participants wear a continuous glucose monitor (CGM) on their skin to track glucose levels for two weeks before starting CPAP. They also consume a specific glucose drink after an overnight fast on two occasions during this period. After using CPAP for at least four weeks, they repeat the same monitoring process. The primary outcome is the difference in average 24-hour glucose levels between when participants use CPAP and when they do not.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
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 65 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
Inclusion Criteria: 1. Community dwelling adult males and females aged 18-65 years 2. Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) ≥15/hr within the past 60 months 3. Able to give written informed consent 4. Proficient in English 6\. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (\<3 months) findings: 1. Fasting glucose with a BGL \<7.0 mmol/L 2. Glucose tolerance with a 2-hour BGL of \< 11.1 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT) 3. HbA1C of ≤ 6.5% 7. Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App. Exclusion Criteria: 1. Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury) 2. Severe mental health disorders (e.g. current major depressive disorder, schizophrenia, bipolar disorder) that in the opinion of the investigator is not adequately treated or will significantly affect their participation in the study. 3. Regular (\>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants) 4. Regular night shift work or travel overseas within the last 2 weeks 5. Sleep physician has advised against CPAP withdrawal 6. Pregnancy 7. Active smoking or routine alcohol use (more than 2 standard drinks a day) or excessive caffeine intake (\>300 mg a day) or recent (in the past month) use of illicit drugs 8. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded) 9. Current or recent (\<3 months) use of hypoglycaemic agents 10. Undergoing a weight loss programme 11. Contraindications for use of the FreeStyle Libre Pro Sensor. E.g. Known hypersensitivity to skin adhesives such as those used to attach the sensor to the arm.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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 2 locations
Woolcock Institute of Medical Research
Macquarie Park, Australia