Metabolic Impact of Intermittent CPAP (MIIC)

Johns Hopkins University

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Other: CPAP withdrawal

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02824263

R01HL135483 (U.S. NIH Grant/Contract)

NA_00086830

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

CPAP (Usual care)

No Intervention group

Description:

Continuation of established CPAP therapy. CPAP will be worn during a metabolic sleep study in the research laboratory.

CPAP withdrawal;

Experimental group

Description:

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.

Treatment:

Other: CPAP withdrawal