CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects

NCT05335083 | Not Yet Recruiting

• 1 other identifier: 2021/ETH12082
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea; Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (28)

• Mean daytime glucose difference between the CPAP on and CPAP off conditions

  2 weeks

• Mean night time glucose

  2 weeks

• Glucose tolerance

  2 weeks

• Coefficient of Variation

  2 Weeks

• SD of Mean Glucose

  2 Weeks

Other Outcomes (4)

• TIR Improvement >10% and <0.5% increase in TBR <3.0 mmol/L

  2 Weeks

• Mean Glucose <8.6 mmol/L and <1% TBR <3.0 mmol/L

  2 Weeks

• TIR >70% and <1% TBR <3.9 mmol/L

  2 Weeks

Study Arms (2)

CPAP off condition

NO INTERVENTION

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

CPAP on condition

EXPERIMENTAL

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

Device: CPAP

Interventions

CPAP DEVICE

A positive CPAP intervention

CPAP on condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 60 months
• Able to give written informed consent
• Proficient in English
• \. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (\<3 months) findings:
• Fasting glucose with a BGL \<7.0 mmol/L
• Glucose tolerance with a 2-hour BGL of \< 11.1 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT)
• HbA1C of ≤ 6.5% 7. Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead

Study Sites (2)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, 2113, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Glucose Intolerance

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Craig L Phillips, PhD

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Sherring, MBBS, DClinD

CONTACT

0407886698; dshe7670@uni.sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)