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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

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Fax 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
Fax 0 0
Email 0 0
[email protected]
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