Metabolic Impact of Intermittent CPAP (MIIC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02824263 |
Recruitment Status :
Completed
First Posted : July 6, 2016
Last Update Posted : June 22, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea | Other: CPAP withdrawal | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Metabolic Impact of Intermittent CPAP |
Actual Study Start Date : | July 10, 2016 |
Actual Primary Completion Date : | June 16, 2022 |
Actual Study Completion Date : | June 16, 2022 |

Arm | Intervention/treatment |
---|---|
No Intervention: CPAP (Usual care)
Continuation of established CPAP therapy. CPAP will be worn during a metabolic sleep study in the research laboratory.
|
|
Experimental: CPAP withdrawal;
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.
|
Other: CPAP withdrawal
CPAP is discontinued for 3 nights. |
- Change in concentration of Free Fatty Acids (FFA, mmol/L) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points ]Serial samples taken during sleep, 29 time points per night, 2 nights
- Change in concentration of Glucose (mg/dl) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points ]Serial samples taken during sleep, 29 time points per night, 2 nights
- Change in concentration of Insulin (mcU/ml) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points ]Serial samples taken during sleep, 29 time points per night, 2 nights
- Change in concentration of Triglycerides (mg/dl) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points ]Serial samples taken during sleep, 29 time points per night, 2 nights
- Serial Oral Glucose Tolerance Test (OGTT) to assess change over time [ Time Frame: 2 nights, <1 month apart, each visit with 5 time points ]Serial samples taken in the morning after each sleep study, 5 time points
- Change in Reactive hyperemia Index (RHI) [ Time Frame: 2 nights, <1 month apart, 1 measurement each visit ]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.
- Change in Augmentation Index (AI) [ Time Frame: 2 nights, <1 month apart, 1 measurement each visit ]Measured in the morning using Itamar EndoPAT device

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824263
United States, Maryland | |
Johns Hopkins Bayview Medical Center | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Jonathan C Jun, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT02824263 |
Other Study ID Numbers: |
NA_00086830 |
First Posted: | July 6, 2016 Key Record Dates |
Last Update Posted: | June 22, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
obstructive sleep apnea CPAP metabolism |
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |