NCT02454153

Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.

Detailed description

Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes. Observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control. However, the impact of treating OSA with positive airway pressure (PAP) therapy on glycemic variability and control is not well defined. Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction. The overarching goal of this study is to determine whether PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.

Conditions

• Sleep Apnea
• Diabetes

Interventions

Type	Name	Description
DEVICE	REMStar Positive Airway Pressure	Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
BEHAVIORAL	LifeStyle Counseling	Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.

Timeline

• Start date: 2014-12-01
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2015-05-27
• Last updated: 2021-05-25
• Results posted: 2021-05-25

Locations

1 site across 1 country: United States