Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
The Impact of CPAP on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea Patients Without Diabetes - an Observational Study
Secondary ID [1] 0 0
2021/ETH12082
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Pre-diabetes 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean 24 hour glucose difference between the CPAP on and CPAP off conditions
Assessment method [1] 0 0
Average 24 hour glucose difference between CPAP on and CPAP off conditions
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Mean daytime glucose difference between the CPAP on and CPAP off conditions
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Mean night time glucose
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
Glucose tolerance
Assessment method [3] 0 0
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
Timepoint [3] 0 0
2 weeks
Secondary outcome [4] 0 0
Coefficient of Variation
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
2 Weeks
Secondary outcome [5] 0 0
SD of Mean Glucose
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
2 Weeks
Secondary outcome [6] 0 0
Time in Range (TIR)
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
2 Weeks
Secondary outcome [7] 0 0
Time Below Range (TBR)
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
2 Weeks
Secondary outcome [8] 0 0
Time below Range <3.0 mmol/L
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
2 Weeks
Secondary outcome [9] 0 0
Time Above Range (TAR)
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
2 Weeks
Secondary outcome [10] 0 0
Time Above Range >13.9 mmol/L
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
2 Weeks
Secondary outcome [11] 0 0
Time in Tight Range (TITR)
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
2 Weeks
Secondary outcome [12] 0 0
Change in Glucose Management Indicator
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
2 Weeks
Secondary outcome [13] 0 0
Extended hypoglycaemic event rate
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
2 Weeks
Secondary outcome [14] 0 0
Extended hyperglycaemic event
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
2 Weeks
Secondary outcome [15] 0 0
TIR >70%
Assessment method [15] 0 0
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.
Timepoint [15] 0 0
2 Weeks
Secondary outcome [16] 0 0
TIR improvement at least 5%
Assessment method [16] 0 0
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.
Timepoint [16] 0 0
2 Weeks
Secondary outcome [17] 0 0
TIR improvement at least 10%
Assessment method [17] 0 0
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.
Timepoint [17] 0 0
2 Weeks
Secondary outcome [18] 0 0
TBR <3.9 mmol/L <4%
Assessment method [18] 0 0
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.
Timepoint [18] 0 0
2 Weeks
Secondary outcome [19] 0 0
TBR <3.0 mmol/L <1%
Assessment method [19] 0 0
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.
Timepoint [19] 0 0
2 Weeks
Secondary outcome [20] 0 0
TAR >10.0 mmol/L >25%
Assessment method [20] 0 0
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.
Timepoint [20] 0 0
2 Weeks
Secondary outcome [21] 0 0
TAR >13.9 mmol/L <5%
Assessment method [21] 0 0
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.
Timepoint [21] 0 0
2 Weeks
Secondary outcome [22] 0 0
Hypoglycaemia
Assessment method [22] 0 0
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.
Timepoint [22] 0 0
2 Weeks
Secondary outcome [23] 0 0
Hypoglycaemia Alert Value (Level 1)
Assessment method [23] 0 0
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.
Timepoint [23] 0 0
2 Weeks
Secondary outcome [24] 0 0
Clinically Significant Hypoglycaemia (Level 2)
Assessment method [24] 0 0
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.
Timepoint [24] 0 0
2 Weeks
Secondary outcome [25] 0 0
Extended Hypoglycaemia
Assessment method [25] 0 0
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.
Timepoint [25] 0 0
2 Weeks
Secondary outcome [26] 0 0
High Glucose Level (Level 1)
Assessment method [26] 0 0
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.
Timepoint [26] 0 0
2 Weeks
Secondary outcome [27] 0 0
Very High Glucose (Level 2)
Assessment method [27] 0 0
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.
Timepoint [27] 0 0
2 Weeks
Secondary outcome [28] 0 0
Extended Hyperglycaemia
Assessment method [28] 0 0
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.
Timepoint [28] 0 0
2 Weeks

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Woolcock Institute of Medical Research - Macquarie Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2113 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Craig L Phillips, PhD
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
David J Sherring, MBBS, DClinD
Address 0 0
Country 0 0
Phone 0 0
0407886698
Email 0 0
dshe7670@uni.sydney.edu.au
Contact person for scientific queries

Data sharing statement


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