Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy



Status:Recruiting
Conditions:Insomnia Sleep Studies, Pulmonary, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 75
Updated:2/10/2019
Start Date:December 2014
End Date:December 2019
Contact:Naresh M Punjabi, MD, PhD
Email:npunjabi@jhmi.edu
Phone:410-550-4891

Use our guide to learn which trials are right for you!

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.

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.

Inclusion Criteria:

- Type 2 diabetics

- Age > 21 and ≤ 75 years

Exclusion Criteria:

- 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
We found this trial at
1
site
4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Principal Investigator: Naresh M Punjabi, MD, PhD
Phone: 410-550-4891
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials