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Not yet recruiting NCT05335083

CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects

No phase Interventional Obstructive Sleep Apnea Pre-diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPAP.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Pre-diabetes. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of CPAP on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea Patients Without Diabetes - An Observational Study

Overview

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 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.

Interventions

  • Device CPAP
    A positive CPAP intervention

Primary outcome measures

  • Mean 24 hour glucose difference between the CPAP on and CPAP off conditions [Time frame: 2 weeks]
Secondary outcome measures (12)
  • Mean daytime glucose difference between the CPAP on and CPAP off conditions [Time frame: 2 weeks]
  • Mean night time glucose [Time frame: 2 weeks]
  • Glucose tolerance [Time frame: 2 weeks]
  • Coefficient of Variation [Time frame: 2 Weeks]
  • SD of Mean Glucose [Time frame: 2 Weeks]
  • Time in Range (TIR) [Time frame: 2 Weeks]
  • Time Below Range (TBR) [Time frame: 2 Weeks]
  • Time below Range <3.0 mmol/L [Time frame: 2 Weeks]
  • Time Above Range (TAR) [Time frame: 2 Weeks]
  • Time Above Range >13.9 mmol/L [Time frame: 2 Weeks]
  • Time in Tight Range (TITR) [Time frame: 2 Weeks]
  • Change in Glucose Management Indicator [Time frame: 2 Weeks]

Eligibility criteria

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

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 2 centers
  • Royal Prince Alfred Hospital — Camperdown
  • Woolcock Institute of Medical Research — Macquarie Park

Identifiers

NCT: NCT05335083 · 2021/ETH12082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗