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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 : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 Device: CPAP withdrawal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 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 2013
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
No Intervention: CPAP
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.
Device: CPAP withdrawal
CPAP is discontinued for 3 nights.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 :
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

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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
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Contact: Chenjuan Gu, MD 410-550-1816 cgu14@jhmi.edu
Contact: Tracy Klopfer 410-550-2380 tracy.klopfer@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Chenjuan Gu    410-550-1816    cgu14@jhmi.edu   
Contact: Tracy Klopfer    4105502380    tracy.klopfer@jhmi.edu   
Principal Investigator: Jonathan C Jun, MD         
Sub-Investigator: Vsevolod Y Polotsky, MD, Ph.D         
Sub-Investigator: Alan R Schwartz, MD         
Sub-Investigator: Philip L Smith, MD         
Sub-Investigator: Susheel Patil, MD, Ph.D         
Sub-Investigator: Jason Kirkness, Ph.D         
Sub-Investigator: Hartmut Schneider, MD, Ph.D         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jonathan C Jun, MD Johns Hopkins University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johns Hopkins University:
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