Obstructive Sleep ApneaMIICNCT02824263
Metabolic Impact of Intermittent CPAP
A study testing CPAP withdrawal in people with Obstructive Sleep Apnea, run by Johns Hopkins University at 1 site in United States.
Trial summary
Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid metabolism during sleep, which over time could lead to diabetes and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2016to 1 Dec 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of moderate to severe Obstructive sleep apnea (OSA) (AHI or respiratory disturbance index (RDI)> 10).
- They must also own a CPAP machine and report the ability to tolerate sleeping with or without CPAP during the night.
Who cannot join
- Uncontrolled hypertension with systolic blood pressure >170 or diastolic blood pressure > 110
- Congestive heart failure
- Use of clonidine or nicotinic acid medication
- Diabetes requiring the use of insulin
- Known pregnancy, by urine testing in women of child-bearing age
- History of falling asleep while driving, near miss
- High risk occupation (pilot, commercial driver)
- Hemoglobin < 10 g/dL on point of care screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid metabolism during sleep, which over time could lead to diabetes and cardiovascular disease. This study examines metabolic changes during sleep in patients with obstructive sleep apnea. Patients accustomed to continuous positive airway pressure (CPAP) therapy are enrolled to undergo sleep studies, either on CPAP therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained so that metabolic function can be compared between sleep apnea and CPAP nights.
Read the detailed description
Participants with a history of moderate severe sleep apnea (AHI>20) will be enrolled if participants meet inclusion/exclusion criteria. Investigators will report to the sleep laboratory on two nights, (1) after continuing their CPAP or (2) after discontinuing CPAP for 3 nights. The order of observation will be randomized. A standard research dinner is provided before each study. IV's are placed so that blood can be sampled at frequent (30 min) intervals throughout the night. In the morning after each study, a glucose tolerance test and endothelial function study (endoPAT) are performed. Serum samples will be analyzed for glucose, insulin, free fatty acids, triglycerides, hormones, and other metabolic biomarkers.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP withdrawal
- Keywords
- obstructive sleep apnea, CPAP, metabolism
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP withdrawalOther
CPAP is discontinued for 3 nights.
| Study group | Role | What they receive |
|---|---|---|
| CPAP (Usual care) | No intervention | Continuation of established CPAP therapy. CPAP will be worn during a metabolic sleep study in the research laboratory. |
| CPAP withdrawal; | Experimental | Cessation of established CPAP therapy for 3 nights. CPAP will NOT be worn during this period, and a metabolic sleep study off CPAP is performed in the research laboratory on the third night. Receives: Other: CPAP withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Plasma Free Fatty Acids (FFA, mmol/L)
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
Concentration of Plasma Glucose (mg/dl)
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
Concentration of Plasma Insulin (mcU/ml)
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
Concentration of Plasma Triglycerides (mg/dl)
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
Secondary outcomes (3)
Oral Glucose Tolerance Test (OGTT)
We will report the mean of the area under the curve (AUC) during OGTT for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.
Reactive Hyperemia Index (RHI)
Measured in the morning using Itamar EndoPAT device. This will measure the ratio of blood flow after brachial artery occlusion to blood flow prior to brachial artery occlusion. Normal values range from approximately 1 to 3 with higher values being associated with better vascular function. We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart, 1 measurement each visit
Augmentation Index (AI)
Measured in the morning using Itamar EndoPAT device. Augmentation index is measured once during each visit, and is expressed as a % increase in the pressure waveform during systole. We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart, 1 measurement each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start10 Jul 2016
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Academy of Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Jonathan C Jun, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824263
- Sponsor's protocol ID
- NA_00086830
- Other IDs
- R01HL135483
- Acronym
- MIIC
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2016
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chopra S, Rathore A, Younas H, Pham LV, Gu C, Beselman A, Kim IY, Wolfe RR, Perin J, Polotsky VY, Jun JC. Obstructive Sleep Apnea Dynamically Increases Nocturnal Plasma Free Fatty Acids, Glucose, and Cortisol During Sleep. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3172-3181. doi: 10.1210/jc.2017-00619.
PubMed 28595341