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CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects

ConditionsObstructive Sleep ApneaPre-diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWoolcock Institute of Medical Research

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • CPAP

    Device

    A positive CPAP intervention

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CPAP off conditionNo intervention 0 interventions
Group B: CPAP on conditionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 weeks

Secondary outcomes

1

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.

Time frame
2 weeks
2

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.

Time frame
2 weeks
3

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

Time frame
2 weeks
4

Coefficient of Variation

Percentage CV intraday (i.e. within 24h) and interday (i.e. over multiple days) between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.

Time frame
2 Weeks

Other outcomes

1

TIR Improvement >10% and <0.5% increase in TBR <3.0 mmol/L

Proportion of participants with \>10% improvement in percentage of TIR 3.9-10.0 mmol/L without an increase in the TBR \<3.0 mmol/L of \>0.5% during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.

Time frame
2 Weeks
2

Mean Glucose <8.6 mmol/L and <1% TBR <3.0 mmol/L

Proportion of participants with Mean Glucose \<8.6 mmol/L and \< 1% TBR \<3.0 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.

Time frame
2 Weeks
3

TIR >70% and <1% TBR <3.9 mmol/L

Proportion of participants with \>70% TIR 3.9-10.0mmol/L and \<4% TBR \<3.9 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.

Time frame
2 Weeks
4

TIR >70% and < 1% TBR <3.0 mmol/L

Proportion of participants with \>70% TIR 3.9-10.0 mmol/L and \<1% TBR \<3.0 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.

Time frame
2 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Woolcock Institute of Medical Research

Lead sponsor

Source ClinicalTrials.gov

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