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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05335083
Registration number
NCT05335083
Ethics application status
Date submitted
12/04/2022
Date registered
19/04/2022
Date last updated
1/04/2025
Titles & IDs
Public title
CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects
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Scientific title
The Impact of CPAP on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea Patients Without Diabetes - an Observational Study
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Secondary ID [1]
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2021/ETH12082
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
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Pre-diabetes
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Metabolic and Endocrine
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - CPAP
No intervention: CPAP off condition - Participants will be monitored for a two-week period prior to commencing CPAP.
Experimental: CPAP on condition - Participants will be monitored for a two-week period at least four weeks following commencement of CPAP.
Treatment: Devices: CPAP
A positive CPAP intervention
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean 24 hour glucose difference between the CPAP on and CPAP off conditions
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Assessment method [1]
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Average 24 hour glucose difference between CPAP on and CPAP off conditions
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Timepoint [1]
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2 weeks
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Secondary outcome [1]
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Mean daytime glucose difference between the CPAP on and CPAP off conditions
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Assessment method [1]
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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.
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Timepoint [1]
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2 weeks
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Secondary outcome [2]
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Mean night time glucose
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Assessment method [2]
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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.
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Timepoint [2]
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2 weeks
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Secondary outcome [3]
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Glucose tolerance
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Assessment method [3]
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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
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Timepoint [3]
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2 weeks
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Secondary outcome [4]
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Coefficient of Variation
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Assessment method [4]
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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.
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Timepoint [4]
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2 Weeks
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Secondary outcome [5]
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SD of Mean Glucose
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Assessment method [5]
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SD of Mean Glucose (daily) during the CPAP on and CPAP off conditions during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [5]
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2 Weeks
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Secondary outcome [6]
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Time in Range (TIR)
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Assessment method [6]
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Percentage of TIR (3.9-10.0 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [6]
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2 Weeks
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Secondary outcome [7]
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Time Below Range (TBR)
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Assessment method [7]
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Percentage of TBR (3.9 mmol/L including readings of \<3 .0 mmol/L) during the the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [7]
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2 Weeks
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Secondary outcome [8]
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Time below Range <3.0 mmol/L
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Assessment method [8]
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Percentage of TBR \<3.0 mmol/L (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [8]
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2 Weeks
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Secondary outcome [9]
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Time Above Range (TAR)
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Assessment method [9]
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Percentage of TAR (\>10.0 mmol/L, including readings \>13.9 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [9]
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2 Weeks
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Secondary outcome [10]
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Time Above Range >13.9 mmol/L
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Assessment method [10]
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Percentage of TAR \>13.9 mmol/L (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [10]
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2 Weeks
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Secondary outcome [11]
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Time in Tight Range (TITR)
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Assessment method [11]
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Percentage of TITR (3.9-7.8 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [11]
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2 Weeks
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Secondary outcome [12]
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Change in Glucose Management Indicator
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Assessment method [12]
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Absolute main change in mmol/L or percentage during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [12]
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2 Weeks
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Secondary outcome [13]
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Extended hypoglycaemic event rate
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Assessment method [13]
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Number of events with sensor glucose \<3.9 mmol/L lasting at least 120 min, event ends when glucose returns to at least 3.9 mmol/L for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [13]
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2 Weeks
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Secondary outcome [14]
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Extended hyperglycaemic event
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Assessment method [14]
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Number of events with sensor glucose \>13.9 mmol/L lasting at least 120 min; event ends when glucose returns to 10 mmol/L or less for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [14]
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2 Weeks
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Secondary outcome [15]
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TIR >70%
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Assessment method [15]
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Proportion of participants with TIR 3.9-10.0 mmol/L for \>70% of the day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [15]
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2 Weeks
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Secondary outcome [16]
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TIR improvement at least 5%
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Assessment method [16]
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Proportion of participants with TIR 3.9-10.0 mmol/L with at least a 5% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [16]
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2 Weeks
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Secondary outcome [17]
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TIR improvement at least 10%
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Assessment method [17]
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Proportion of participants with TIR 3.9-10.0 mmol/L with at least a 10% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [17]
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2 Weeks
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Secondary outcome [18]
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TBR <3.9 mmol/L <4%
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Assessment method [18]
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Proportion of participants with TBR \<3.9 mmol/L for \<4% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [18]
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2 Weeks
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Secondary outcome [19]
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TBR <3.0 mmol/L <1%
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Assessment method [19]
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Proportion of participants with TBR \<3.0 mmol/L for \<1% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [19]
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2 Weeks
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Secondary outcome [20]
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TAR >10.0 mmol/L >25%
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Assessment method [20]
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Proportion of participants with a TAR \>10.0 mmol/L for \<25% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [20]
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2 Weeks
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Secondary outcome [21]
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TAR >13.9 mmol/L <5%
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Assessment method [21]
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Proportion of participants with TAR \>13.9 mmol/L for \<5% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [21]
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2 Weeks
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Secondary outcome [22]
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Hypoglycaemia
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Assessment method [22]
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Number of times CGM sensor values are \<3.9 mmol/L (including readings of \<3.0 mmol/L) for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol/L.
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Timepoint [22]
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2 Weeks
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Secondary outcome [23]
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Hypoglycaemia Alert Value (Level 1)
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Assessment method [23]
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Number of times CGM sensor values are 3.0-3.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol/L.
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Timepoint [23]
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2 Weeks
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Secondary outcome [24]
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Clinically Significant Hypoglycaemia (Level 2)
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Assessment method [24]
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Number of times CGM sensor values are \<3.0 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.0 mmol/L.
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Timepoint [24]
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2 Weeks
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Secondary outcome [25]
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Extended Hypoglycaemia
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Assessment method [25]
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Number of times CGM sensor values are \<3.9 mmol/L for at least 120 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [25]
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2 Weeks
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Secondary outcome [26]
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High Glucose Level (Level 1)
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Assessment method [26]
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Number of times CGM sensor values are 10.1-13.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 10 mmol/L.
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Timepoint [26]
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2 Weeks
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Secondary outcome [27]
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Very High Glucose (Level 2)
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Assessment method [27]
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Number of times CGM sensor values are \>13.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 13.9 mmol/L.
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Timepoint [27]
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2 Weeks
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Secondary outcome [28]
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Extended Hyperglycaemia
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Assessment method [28]
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Number of times CGM sensor values are \>13.9 mmol/L for at least 90 consecutive minutes within a 120-minute period during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods.
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Timepoint [28]
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2 Weeks
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Eligibility
Key inclusion criteria
1. Community dwelling adult males and females aged 18-65 years
2. Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) =15/hr within the past 60 months
3. Able to give written informed consent
4. Proficient in English
6. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (<3 months) findings:
1. Fasting glucose with a BGL <7.0 mmol/L
2. Glucose tolerance with a 2-hour BGL of < 11.1 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT)
3. HbA1C of = 6.5% 7. Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury)
2. 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.
3. Regular (>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants)
4. Regular night shift work or travel overseas within the last 2 weeks
5. Sleep physician has advised against CPAP withdrawal
6. Pregnancy
7. 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
8. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)
9. Current or recent (<3 months) use of hypoglycaemic agents
10. Undergoing a weight loss programme
11. 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/02/2027
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Woolcock Institute of Medical Research - Macquarie Park
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2113 - Macquarie Park
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Funding & Sponsors
Primary sponsor type
Other
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Name
Woolcock Institute of Medical Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT05335083
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Craig L Phillips, PhD
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Address
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Woolcock Institute of Medical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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David J Sherring, MBBS, DClinD
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Address
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Country
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Phone
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0407886698
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
All data will be deidentified using a unique study ID.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05335083
Download to PDF