N/A
N=184
Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Sleep Apnea · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02454153 ↗Enrolled (actual)
184
Serious AEs
0.5%
Results posted
May 2021
Primary outcome: Primary: Change in Continuous Glucose Monitoring System Standard Deviation — 0.8; 1.1 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- REMStar Positive Airway Pressure (Device); LifeStyle Counseling (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Continuous Glucose Monitoring System Standard Deviation |
0.8; 1.1 | — |
| SECONDARY Mean Difference in Systolic Blood Pressure |
-7.3; 7.4 | — |
| SECONDARY Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index |
-0.0014; 0.0024 | — |
| SECONDARY Heart Rate Variability |
— | — |
| SECONDARY Change in the Epworth Sleepiness Scale |
-2.5; -1.3 | — |
| SECONDARY Change in Post-Pre Meal Blood Glucose Levels |
-9.9; -1.3; 1.0; -6.1; -3.0; 3.7 | — |
| SECONDARY Change in Glycosylated Hemoglobin A1c Level |
0.2; 0.2 | — |
| SECONDARY Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion |
69.5; 71.4 | — |
| SECONDARY Continuous Glucose Monitoring System Standard Deviation |
38.7; 39.2 | — |
| SECONDARY Change in Continuous Glucose Monitoring System Mean Glucose |
4.3; 9.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02454153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.