Not yet recruitingNo phase
CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects
Key facts
- Who runs it
- Woolcock Institute of Medical Research
- Where
- Australia2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- 1 Jul 2025
- Expected to end
- 28 Feb 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- CPAP
- Record updated
- 1 April 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- Regular (>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants)
- 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)
- 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
- 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
- Regular night shift work or travel overseas within the last 2 weeks
- Sleep physician has advised against CPAP withdrawal
- Pregnancy
- Current or recent (<3 months) use of hypoglycaemic agents
- Undergoing a weight loss programme
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.
The 2 groups in the trial
- CPAP off conditionNo study treatment, for comparison
Participants will be monitored for a two-week period prior to commencing CPAP.
- CPAP on conditionTreatment being tested
Participants will be monitored for a two-week period at least four weeks following commencement of CPAP.
Treatment: CPAP
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Impact of CPAP on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea Patients Without Diabetes - An Observational Study
- Fit questions
- Built from NCT05335083, who can take part
- Record updated
- 1 April 2025