Clinical trial NCT02454153: Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Official title: Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Diabetes
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-05-27
Enrollment: 184
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Continuous Glucose Monitoring System Standard Deviation
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Mean Difference in Systolic Blood Pressure
timeFrame: Baseline and 3 months
measure: Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index
timeFrame: Baseline and 3 months
measure: Heart Rate Variability
timeFrame: 3 months
measure: Change in the Epworth Sleepiness Scale
timeFrame: Baseline and 3 months
measure: Change in Post-Pre Meal Blood Glucose Levels
timeFrame: Baseline and 3 months
measure: Change in Glycosylated Hemoglobin A1c Level
timeFrame: Baseline and 3 months
measure: Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion
timeFrame: 3 months
measure: Continuous Glucose Monitoring System Standard Deviation
timeFrame: 3 months
measure: Change in Continuous Glucose Monitoring System Mean Glucose
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Naresh M Punjabi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rooney MR, Aurora RN, Wang D, Selvin E, Punjabi NM. Rationale and design of the Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) trial. Contemp Clin Trials. 2021 Feb;101:106248. doi: 10.1016/j.cct.2020.106248. Epub 2020 Dec 11.