Status:
NOT_YET_RECRUITING
CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects
Lead Sponsor:
Woolcock Institute of Medical Research
Conditions:
Obstructive Sleep Apnea
Pre-diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.
Detailed Description
Glucose metabolism in patients newly diagnosed with moderate-severe OSA and without diabetes will be monitored for two weeks prior to commencement of CPAP using a CGM. They will consume a 75g oral glu...
Eligibility Criteria
Inclusion
- Community dwelling adult males and females aged 18-65 years
- Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) ≥15/hr within the past 60 months
- Able to give written informed consent
- Proficient in English
- 6\. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (\<3 months) findings:
- Fasting glucose with a BGL \<7.0 mmol/L
- Glucose tolerance with a 2-hour BGL of \< 11.1 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT)
- 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
- Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury)
- 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.
- Regular (\>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants)
- Regular night shift work or travel overseas within the last 2 weeks
- Sleep physician has advised against CPAP withdrawal
- Pregnancy
- 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
- Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)
- Current or recent (\<3 months) use of hypoglycaemic agents
- Undergoing a weight loss programme
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05335083
Start Date
July 1 2025
End Date
February 28 2027
Last Update
April 1 2025
Active Locations (2)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia, 2113