Back to resultsCPAP Withdrawal and Glucose Metabolism in OSA With Pre-diabetes
Primary Purpose
Obstructive Sleep Apnea, Pre-diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CPAP withdrawal
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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 24 months
- Able to give written informed consent
- Proficient in English
- Established CPAP use for at least 1 month with objectively confirmed average use ≥5 hours per night on ≥5 nights per week in the previous 2 weeks. Mean CPAP machine determined AHI<5 events per hour determined over the previous 2 weeks.
Diagnosed pre-diabetes defined by the American Diabetes Association as any of the following recent (<3 months) findings:
- Impaired fasting glucose with a BGL of 5.6 to 6.9 mmol/L
- Impaired glucose tolerance with a 2-hour BGL of 7.8 to 11.0 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT)
- HbA1C of 5.7% to 6.4%
- 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.
Sites / Locations
- Woolcock Institute of Medical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CPAP on condition
CPAP off condition
Arm Description
Participants in this arm will begin by using their CPAP as per usual for 2 weeks. Then they will undergo 2 weeks of CPAP withdrawal and stop using their CPAP machine.
Participants in this arm will withdraw from their regular CPAP use for 2 weeks. They will then resume their CPAP use for 2 weeks as usual.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Glucose tolerance test
Difference in glucose tolerance as measured by peak 2-hour post 75g glucose load during an Oral Glucose Tolerance Test (OGTT) measured at the end of each 2-week CPAP on and CPAP off conditions.
Insulin sensitivity
Difference in insulin sensitivity as measured by Minimal Model Assessment (MINMOD) during a 75g glucose load during an OGTT measured at the end of each 2-week CPAP on and CPAP off conditions.
Full Information
NCT ID
NCT05335083
First Posted
April 12, 2022
Last Updated
September 19, 2023
Sponsor
Woolcock Institute of Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT05335083
Brief Title
CPAP Withdrawal and Glucose Metabolism in OSA With Pre-diabetes
Official Title
The Impact of 2 Weeks CPAP Withdrawal on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea With Pre-diabetes - A Randomised Controlled Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
December 14, 2023 (Anticipated)
Study Completion Date
December 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woolcock Institute of Medical Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the current study is to investigate whether temporary, 2-week, CPAP withdrawal will adversely impact glucose metabolism
Detailed Description
Patients with moderate severe OSA and pre-diabetes who are established and compliant CPAP users will be randomised to withdraw or remain on CPAP for 2 weeks before crossing over to the alternative treatment arm. Glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Pre-diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Masking Description
Investigator performing data analysis will be blinded
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP on condition
Arm Type
Experimental
Arm Description
Participants in this arm will begin by using their CPAP as per usual for 2 weeks. Then they will undergo 2 weeks of CPAP withdrawal and stop using their CPAP machine.
Arm Title
CPAP off condition
Arm Type
Experimental
Arm Description
Participants in this arm will withdraw from their regular CPAP use for 2 weeks. They will then resume their CPAP use for 2 weeks as usual.
Intervention Type
Device
Intervention Name(s)
CPAP withdrawal
Intervention Description
A negative CPAP intervention
Primary Outcome Measure Information:
Title
Mean 24 hour glucose difference between the CPAP on and CPAP off conditions
Description
Average 24 hour glucose difference between CPAP on and CPAP off conditions
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Mean daytime glucose difference between the CPAP on and CPAP off conditions
Description
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
Title
Mean night time glucose
Description
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
Title
Glucose tolerance test
Description
Difference in glucose tolerance as measured by peak 2-hour post 75g glucose load during an Oral Glucose Tolerance Test (OGTT) measured at the end of each 2-week CPAP on and CPAP off conditions.
Time Frame
2 weeks
Title
Insulin sensitivity
Description
Difference in insulin sensitivity as measured by Minimal Model Assessment (MINMOD) during a 75g glucose load during an OGTT measured at the end of each 2-week CPAP on and CPAP off conditions.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 24 months
Able to give written informed consent
Proficient in English
Established CPAP use for at least 1 month with objectively confirmed average use ≥5 hours per night on ≥5 nights per week in the previous 2 weeks. Mean CPAP machine determined AHI<5 events per hour determined over the previous 2 weeks.
Diagnosed pre-diabetes defined by the American Diabetes Association as any of the following recent (<3 months) findings:
Impaired fasting glucose with a BGL of 5.6 to 6.9 mmol/L
Impaired glucose tolerance with a 2-hour BGL of 7.8 to 11.0 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT)
HbA1C of 5.7% to 6.4%
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David J Sherring, MBBS, DClinD
Phone
0407886698
Email
dshe7670@uni.sydney.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig L Phillips, PhD
Organizational Affiliation
Woolcock Institute of Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woolcock Institute of Medical Research
City
Glebe
State/Province
New South Wales
ZIP/Postal Code
2095
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grigori Kaplan, PhD
Phone
+61 9114 0412
Email
grigori.kaplan@sydney.edu.au
First Name & Middle Initial & Last Name & Degree
Craig Phillips, PhD
First Name & Middle Initial & Last Name & Degree
Keith Wong, PhD FRACP
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data will be deidentified using a unique study ID.
Learn more about this trial
CPAP Withdrawal and Glucose Metabolism in OSA With Pre-diabetes
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