CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects

NCT ID: NCT05335083

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-02-28

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.

Detailed Description

Glucose metabolism in patients newly diagnosed with moderate-severe OSA and without diabetes will be monitored for two weeks prior to commencement of CPAP using a CGM. They will consume a 75g oral glucose drink fasted on waking twice during the two-week monitoring period, having consumed a standardised meal the evening prior. After establishing CPAP use for at least four weeks they will undergo the same protocol as for the observation period prior to commencing CPAP. Glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.

Conditions

Obstructive Sleep Apnea; Pre-diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP off condition

Participants will be monitored for a two-week period prior to commencing CPAP.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CPAP on condition

Participants will be monitored for a two-week period at least four weeks following commencement of CPAP.

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

A positive CPAP intervention

Interventions

CPAP

A positive CPAP intervention

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Woolcock Institute of Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig L Phillips, PhD

Role: PRINCIPAL_INVESTIGATOR

Woolcock Institute of Medical Research

Locations

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia

Countries

Australia

Central Contacts

David J Sherring, MBBS, DClinD

Role: CONTACT

dshe7670@uni.sydney.edu.au

0407886698

Facility Contacts

Estelle Ali

Role: primary

estelle.ali@health.nsw.gov.au

+61 468805641

Grigori Kaplan, PhD

Role: primary

grigori.kaplan@sydney.edu.au

+61 9114 0412

Other Identifiers

2021/ETH12082

Identifier Type: -

Identifier Source: org_study_id