Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy

Completed · Not applicable

Conditions studied: Sleep Apnea, Diabetes

In brief

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.

Key facts

Study ID

NCT02454153

Run by

Johns Hopkins University

People needed

184

Starts

2014-12-01

Expected to finish

2020-03-15

Last updated by the study team

2021-05-25

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetics
• Age > 21 and ≤ 75 years

You may not qualify if…

• Inability to consent or commit to the required visits
• Use of insulin or other injections for diabetes
• Weight change of 10% in last six months
• Use of oral steroids in the last six months
• Pulmonary disease (i.e., COPD)
• Renal or hepatic insufficiency
• Recent MI or stroke (< 3 months)
• Sleep-related hypoventilation
• Obesity-hypoventilation syndrome
• Morbid Obesity
• Occupation as a commercial driver or operator of heavy machinery
• Active substance use
• Untreated thyroid disease
• Pregnancy
• Any history of seizures or other neurologic disease
• Poor sleep hygiene or sleep disorder other than sleep apnea
• Central sleep apnea
• Variants of obstructive sleep apnea (e.g., REM-related OSA)
• Participants not suitable for the study based on the clinical judgment
• Use of any investigational drug within the past 30 days
• Participating in another study

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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