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NCT Number: NCT02454153

Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy

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.

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Key information

Conditions

Sleep Apnea Apnea Diabetes Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REMStar Positive Airway Pressure

Device

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

Lifestyle Counseling

Behavioral

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

Primary outcomes

  1. Change in Continuous Glucose Monitoring System Standard Deviation

    Time frame: Baseline and 3 months

    Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.

Secondary outcomes

  1. Mean Difference in Systolic Blood Pressure

    Time frame: Baseline and 3 months

    Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group.

  2. Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index

    Time frame: Baseline and 3 months

    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.

  3. Heart Rate Variability

    Time frame: 3 months

  4. Change in the Epworth Sleepiness Scale

    Time frame: Baseline and 3 months

    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

  5. Change in Post-Pre Meal Blood Glucose Levels

    Time frame: Baseline and 3 months

    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.

  6. Change in Glycosylated Hemoglobin A1c Level

    Time frame: Baseline and 3 months

    Change in point-of-care hemoglobin A1c (%) after three months.

  7. Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion

    Time frame: 3 months

    Mean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months).

  8. Continuous Glucose Monitoring System Standard Deviation

    Time frame: 3 months

    The standard deviation of the glucose from continuous glucose monitoring at three months.

  9. Change in Continuous Glucose Monitoring System Mean Glucose

    Time frame: Baseline and 3 months

    Continuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: HYPNOS

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 27, 2015
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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