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Metabolic Impact of Intermittent CPAP (MIIC)

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP withdrawal
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, CPAP, metabolism

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

CPAP (Usual care)

CPAP withdrawal;

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in concentration of Free Fatty Acids (FFA, mmol/L)
Serial samples taken during sleep, 29 time points per night, 2 nights
Change in concentration of Glucose (mg/dl)
Serial samples taken during sleep, 29 time points per night, 2 nights
Change in concentration of Insulin (mcU/ml)
Serial samples taken during sleep, 29 time points per night, 2 nights
Change in concentration of Triglycerides (mg/dl)
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
Serial samples taken in the morning after each sleep study, 5 time points
Change in 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.
Change in Augmentation Index (AI)
Measured in the morning using Itamar EndoPAT device

Full Information

First Posted
March 18, 2016
Last Updated
October 3, 2023
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Academy of Sleep Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02824263
Brief Title
Metabolic Impact of Intermittent CPAP
Acronym
MIIC
Official Title
Metabolic Impact of Intermittent CPAP
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2016 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Academy of Sleep Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, CPAP, metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan C Jun, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28595341
Citation
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.
Results Reference
derived

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Metabolic Impact of Intermittent CPAP

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