Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy (HYPNOS)

Johns Hopkins University

Status: Completed

Conditions: Diabetes; Sleep Apnea

Treatments: Behavioral: LifeStyle Counseling; Device: REMStar Positive Airway Pressure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02454153

R01HL117167 (U.S. NIH Grant/Contract)

NA_00093188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

REMStar Positive Airway Pressure

Active Comparator group

Description:

Positive pressure therapy is the standard of care for managing obstructive sleep apnea.

Treatment:

Device: REMStar Positive Airway Pressure

LifeStyle Counseling

Other group

Description:

Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.

Treatment:

Behavioral: LifeStyle Counseling