Sleep Disordered Breathing in Marfan Syndrome: Susceptibility and Hemodynamics (MSB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03985657|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 17, 2019
The main thrust of the research is based on evidence that 1) there is a higher prevalence of obstructive sleep apnea (OSA) in patients with Marfan syndrome (MFS) compared to those without MFS and 2) that there could be an association between OSA and aortic dissection, the main cause of morbidity and mortality in this patient subset.
The increased prevalence is thought to be due to increased collapsibility of the upper airway but this has not been characterized physiologically. Also, it is thought that the hemodynamic stress associated with OSA may contribute to aortic disease in MFS.
In this project therefore, the investigators will estimate the closing pressure of the upper airway in MFS patients and matched non-MFS controls to determine susceptibility. The investigators will also examine the hemodynamic responses in periods of obstructed breathing and explore the relationship between these responses and aortic vascular parameters in MFS.
|Condition or disease||Intervention/treatment||Phase|
|Sleep-disordered Breathing Snoring||Device: CPAP||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be assigned to a Baseline or CPAP polysomnography in a randomized fashion. Baseline study represents the exposure to sleep disordered breathing and the CPAP study represents the relief of the exposure. Markers of hemodynamic stress will be assessed in the morning after both studies.|
|Masking:||None (Open Label)|
|Official Title:||Sleep Disordered Breathing in Marfan Syndrome: Susceptibility and Hemodynamics|
|Actual Study Start Date :||June 6, 2018|
|Estimated Primary Completion Date :||December 18, 2019|
|Estimated Study Completion Date :||December 18, 2019|
No Intervention: Baseline Sleep Study
Baseline sleep polysomnography will involve collection of electroencephalogram, electromyogram, electrocardiogram, airflow, heart rate, blood pressure and pleural pressure during sleep with no CPAP.
Experimental: CPAP Sleep Study
Participants will be treated with continuous positive airway pressure to relieve sleep disordered breathing
Continuous positive airway pressure (CPAP). Room air at pressures between 6-8 centimeters of water (cmH2O) delivered via heated humidified tubing and a nasal mask.
- Critical closing pressure of the upper airway (Pcrit) [ Time Frame: 2 nights ]Pressure at which the pharynx collapses during sleep in cmH2O.
- Mean arterial blood pressure [ Time Frame: 2 nights ]Overnight assessment of mean arterial blood pressure in mmHg.
- Mean Heart Rate [ Time Frame: 2 nights ]Overnight assessment of mean heart rate in beats per minute (bpm).
- Mean pleural pressure [ Time Frame: 2 nights ]Overnight assessment of mean pleural pressure swings in cmH2O.
- Arterial stiffness as assessed by the Augmentation Index [ Time Frame: 15 minutes ]Morning (post night study) assessment of augmentation Index a measure of arterial stiffness. It can range from -10% to +30% in healthy individuals, with values increasing with age and arterial stiffness.
- Endothelial function as assessed by Hyperemia Index [ Time Frame: 15 minutes ]Morning (post night study) assessment of reactive hyperemia index a measure of endothelial function. It is unitless and can range from 1 to 3 in healthy individuals with lower values indicating poor endothelial function.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985657
|Contact: Mariah Chaneyemail@example.com|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Mariah Chaney 410-550-2233 firstname.lastname@example.org|
|Principal Investigator:||Mudiaga Sowho||Johns Hopkins University|