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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

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05335083

    Intervention or treatment

    DEVICE: CPAP

    Conditions

    • Obstructive Sleep Apnea
    • Pre-diabetes

    Find a site

    Closest Location:

    Woolcock Institute of Medical Research

    Research sites nearby

    Select from list below to view details:

    • Woolcock Institute of Medical Research

      Macquarie Park, New South Wales, Australia

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Mean 24 hour glucose difference between the CPAP on and CPAP off conditionsAverage 24 hour glucose difference between CPAP on and CPAP off conditions2 weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Mean daytime glucose difference between the CPAP on and CPAP off conditionsMean 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 glucoseMean 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 toleranceDifference in glucose tolerance as measured by peak 2-hour post 75g glucose load administered twice during each two-week observation period using a CGM2 weeks

    Frequently Asked Questions

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    References

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

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