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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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