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CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects

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The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.

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Study details:

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 glucose drink fasted on waking twice during the two-week monitoring period, having consumed a standardised meal the evening prior. After establishing CPAP use for at least four weeks they will undergo the same protocol as for the observation period prior to commencing CPAP.

Glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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%

Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.

Exclusion criteria

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-07-01

Primary completion: 2025-02-28

Study completion finish: 2025-02-28

Study type

TREATMENT

Phase

Trial ID

NCT05335083

Intervention or treatment

DEVICE: CPAP

Conditions

• Obstructive Sleep Apnea
• Pre-diabetes

Image related to Obstructive Sleep Apnea

Condition: Obstructive Sleep Apnea, Pre-diabetes
DEVICE: CPAP
Macquarie Park, New South Wales, Australia
Sponsor: Woolcock Institute of Medical Research

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Woolcock Institute of Medical Research

Research sites nearby

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Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
NO_INTERVENTION: CPAP off condition Participants will be monitored for a two-week period prior to commencing CPAP.	Not specified
EXPERIMENTAL: CPAP on condition Participants will be monitored for a two-week period at least four weeks following commencement of CPAP.	DEVICE: CPAP A positive CPAP intervention

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Mean 24 hour glucose difference between the CPAP on and CPAP off conditions	Average 24 hour glucose difference between CPAP on and CPAP off conditions	2 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Mean daytime glucose difference between the CPAP on and CPAP off conditions	Mean Daytime (6:00 AM - 10:00 PM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.	2 weeks
Mean night time glucose	Mean Night-time (10:00 PM - 6:00 AM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.	2 weeks
Glucose tolerance	Difference in glucose tolerance as measured by peak 2-hour post 75g glucose load administered twice during each two-week observation period using a CGM	2 weeks

Frequently Asked Questions

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References

Clinical Trials Gov: CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects