Metabolic Impact of Intermittent CPAP

Obstructive Sleep Apnea Clinical Trial

— MIIC  

Official title:

Metabolic Impact of Intermittent CPAP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824263
• Other study ID #: NA_00086830
• Secondary ID: R01HL135483
• Status: Completed
• Phase: N/A
• Start date: July 10, 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• CPAP withdrawal
CPAP is discontinued for 3 nights.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	American Academy of Sleep Medicine, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Plasma Free Fatty Acids (FFA, mmol/L)	We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).	2 nights, <1 month apart. Data from each night was averaged to report a single value.
Primary	Concentration of Plasma Glucose (mg/dl)	We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).	2 nights, <1 month apart. Data from each night was averaged to report a single value.
Primary	Concentration of Plasma Insulin (mcU/ml)	We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).	2 nights, <1 month apart. Data from each night was averaged to report a single value.
Primary	Concentration of Plasma Triglycerides (mg/dl)	We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).	2 nights, <1 month apart. Data from each night was averaged to report a single value.
Secondary	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).	2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.
Secondary	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).	2 nights, <1 month apart, 1 measurement each visit
Secondary	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).	2 nights, <1 month apart, 1 measurement each visit