Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy

Diabetes Clinical Trial

— HYPNOS  

Official title:

Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454153
• Other study ID #: NA_00093188
• Secondary ID: R01HL117167
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 15, 2020

Study information

• Verified date: May 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Diabetes
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Continuous Glucose Monitoring System Standard Deviation	Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.	Baseline and 3 months
Secondary	Mean Difference in Systolic Blood Pressure	Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group.	Baseline and 3 months
Secondary	Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index	Endothelial function was measured by the EndoPAT device - difference at 3 months - baseline, by group. The outcome reported is the Reactive Hyperemic Index (RHI). The RHI is a measure of endothelial vasodilator function. The RHI is the post-to-pre occlusion peripheral arterial tone signal ratio in the occluded arm relative to the other arm, which is not occluded. Persons with worse endothelial function have a lower RHI score. Consequently, a low RHI indicates more endothelial dysfunction. A value of 1.67 or less is considered abnormal vascular tone. The reported lower and upper limits in adults with type 2 diabetes is 1.1 - 4.9.	Baseline and 3 months
Secondary	Heart Rate Variability		3 months
Secondary	Change in the Epworth Sleepiness Scale	The Epworth Sleepiness Scale measures self-reported sleep propensity or daytime sleepiness. The range of the scale is 0 to 24 (integers only), with increasing values corresponding to increasing sleepiness. A cut-point of = 11 is also sometimes used to differentiate those with pathological sleepiness (= 11) versus those without < 11. The difference between the three month final visit - the baseline visit score is reported by group	Baseline and 3 months
Secondary	Change in Post-Pre Meal Blood Glucose Levels	The difference from baseline to three months in self-reported in blood glucose levels before and after meals (mg/dL) (post-meal - pre-meal). Data is presented for breakfast, lunch, and dinner.	Baseline and 3 months
Secondary	Change in Glycosylated Hemoglobin A1c Level	Change in point-of-care hemoglobin A1c (%) after three months.	Baseline and 3 months
Secondary	Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion	Mean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months).	3 months
Secondary	Continuous Glucose Monitoring System Standard Deviation	The standard deviation of the glucose from continuous glucose monitoring at three months.	3 months
Secondary	Change in Continuous Glucose Monitoring System Mean Glucose	Continuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months.	Baseline and 3 months