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Metabolic Impact of Intermittent CPAP (MIIC)

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ClinicalTrials.gov Identifier: NCT02824263
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE March 18, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date March 9, 2021
Actual Study Start Date  ICMJE July 10, 2016
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • Free Fatty Acids (FFA, mmol/L) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points to assess change over time ]
    Serial samples taken during sleep, 29 time points per night, 2 nights
  • Glucose (mg/dl) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points to assess change over time ]
    Serial samples taken during sleep, 29 time points per night, 2 nights
  • Insulin (mcU/ml) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points to assess change over time ]
    Serial samples taken during sleep, 29 time points per night, 2 nights
  • Triglycerides (mg/dl) [ Time Frame: 2 nights, <1 month apart, each visit with 29 time points to assess change over time ]
    Serial samples taken during sleep, 29 time points per night, 2 nights
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • Oral Glucose Tolerance Test (OGTT) [ Time Frame: 2 nights, <1 month apart, each visit with 5 time points to assess change over time ]
    Serial samples taken in the morning after each sleep study, 5 time points
  • Reactive hyperemia Index [ Time Frame: 2 nights, <1 month apart, 1 measurement each visit ]
    Measured in the morning using Itamar EndoPAT device
  • C-reactive protein (mg/L) [ Time Frame: 2 nights, <1 month apart, 1 measurement each visit ]
    Measured twice (CPAP/no CPAP) in the morning
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Impact of Intermittent CPAP
Official Title  ICMJE Metabolic Impact of Intermittent CPAP
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE Other: CPAP withdrawal
CPAP is discontinued for 3 nights.
Study Arms  ICMJE
  • 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.
    Intervention: Other: CPAP withdrawal
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2016)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mariah Chaney 410-550-2233 mchaney7@jhmi.edu
Contact: Chenjuan Gu 410-550-1816 cgu14@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824263
Other Study ID Numbers  ICMJE NA_00086830
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan C Jun, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP