Metabolic Impact of Intermittent CPAP (MIIC)
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| ClinicalTrials.gov Identifier: NCT02824263 |
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Recruitment Status :
Recruiting
First Posted : July 6, 2016
Last Update Posted : March 9, 2021
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Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins University
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Brief 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. This study examines metabolic changes during sleep in patients with obstructive sleep apnea. Patients accustomed to 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obstructive Sleep Apnea | Other: CPAP withdrawal | Not Applicable |
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.
| 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 |
| Estimated Primary Completion Date : | February 2023 |
| Estimated Study Completion Date : | February 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Obstructive sleep apnea
MedlinePlus related topics:
Sleep Apnea
| Arm | Intervention/treatment |
|---|---|
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No Intervention: CPAP (Usual care)
Continuation of established CPAP therapy. CPAP will be worn during a metabolic sleep study in the research laboratory.
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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.
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Other: CPAP withdrawal
CPAP is discontinued for 3 nights. |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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 concentration of C-reactive protein (mg/L) [ Time Frame: 2 nights, <1 month apart, 1 measurement each visit ]Measured twice (CPAP/no CPAP) in the morning
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| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Contacts
| Contact: Mariah Chaney | 410-550-2233 | mchaney7@jhmi.edu | |
| Contact: Chenjuan Gu | 410-550-1816 | cgu14@jhmi.edu |
Locations
| United States, Maryland | |
| Johns Hopkins Bayview Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Mariah Chaney 410-550-2233 mchaney7@jhmi.edu | |
| Principal Investigator: Jonathan C Jun, MD | |
| Sub-Investigator: Chenjuan Gu | |
| Principal Investigator: Mudiaga Sowho | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Jonathan C Jun, MD | Johns Hopkins University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | March 9, 2021 |
| Last Verified: | March 2021 |
| 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 |
Keywords provided by Johns Hopkins University:
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obstructive sleep apnea CPAP metabolism |
Additional relevant MeSH terms:
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Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |