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Completed

NCT Number: NCT02824263

Metabolic Impact of Intermittent CPAP

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP withdrawal

Other

CPAP is discontinued for 3 nights.

Primary outcomes

  1. Concentration of Plasma Free Fatty Acids (FFA, mmol/L)

    Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.

    We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

  2. Concentration of Plasma Glucose (mg/dl)

    Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.

    We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

  3. Concentration of Plasma Insulin (mcU/ml)

    Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.

    We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

  4. Concentration of Plasma Triglycerides (mg/dl)

    Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.

    We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

Secondary outcomes

  1. Oral Glucose Tolerance Test (OGTT)

    Time frame: 2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.

    We will report the mean of the area under the curve (AUC) during OGTT for all participants per group (CPAP vs. CPAP withdrawal).

  2. 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. We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

  3. Augmentation Index (AI)

    Time frame: 2 nights, <1 month apart, 1 measurement each visit

    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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Academy of Sleep Medicine
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: MIIC

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2016
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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