Hemodynamics Response to Upper Airway Obstruction in Marfan Syndrome

Snoring Clinical Trial

— MSB  

Official title:

Sleep Disordered Breathing in Marfan Syndrome: Susceptibility and Hemodynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985657
• Other study ID #: IRB00157403
• Status: Completed
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: December 6, 2019

Study information

• Verified date: December 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper airway obstruction (UAO) is an unrecognized source of hemodynamic stress that may contribute to aortic adverse events in persons with Marfan Syndrome (MFS). UAO occurs during snoring and sleep apnea and is characterized by repetitive partial or complete obstruction of the upper airway during sleep. These obstructive breathing events lead to intermittent surges in blood pressure (BP) REF and large decreases in pleural pressure (Pes), thereby increasing the trans-mural aortic pressure (TMP) and imposing mechanical stress on the aorta during sleep. Although UAO is known to increase mechanical stress on the aorta, the magnitude of the increase is not known for persons with MFS.

In this project, therefore, the investigators will also examine the changes in Pes and BP responses in periods of obstructed breathing and compare the diurnal markers or vascular stress between Baseline and CPAP studies in MFS persons.

Description:

Research Objective/Significance:

Specific Aim 1a: To quantify the Pes and BP during periods with and without UAO during sleep in persons with MFS.

Specific Aim 1b: To examine the effect of CPAP treatment of UAO on Pes and BP in MFS persons.

Specific Aim 2: To examine the effect of CPAP treatment of UAO on daytime markers of hemodynamic stress (augmentation index, reactive hyperemia index) in MFS persons.

Primary Outcomes:

• Overnight measure of hemodynamic stress (blood pressure, pleural pressure swings)

Secondary Outcomes:

• Changes in diurnal markers of hemodynamic stress (augmentation index, reactive hyperemia index)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 6, 2019
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

People with Marfan syndrome.

• Age = 18yrs

• Able and willing to provide informed consent

• Willing to sleep connected to research apparatus

Exclusion Criteria:

• Unstable cardiovascular disease (CHF, myocardial infarction or revascularization procedures, and unstable arrhythmias)

• Uncontrolled hypertension (BP > 190/110)

• Underlying obstructive or other intrinsic lung disease

• Renal failure on dialysis

• Cirrhosis

• Pregnancy

Related Conditions & MeSH terms

• Marfan Syndrome
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-disordered Breathing
• Snoring

Intervention

Device:
• CPAP
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institutes of Health (NIH), The Marfan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pleural Pressure (Pes)	Pleural pressure (Pes) in mmHg monitored using an esophageal catheter.	Overnight on both CPAP and No CPAP nights
Primary	Mean Arterial Blood Pressure (MAP)	Continuous blood pressure monitored using a non-invasive finger cuff. Data captured in mmHg.	Overnight on both Baseline and CPAP studies
Secondary	Augmentation Index (AI)	The AI (measured as "percentage of pulse pressure") was assessed in the morning after both Baseline and CPAP studies. It is a measure of arterial stiffness that represents the degree of and can range from -10% to +10% in healthy individuals, with values generally higher in females and increases with age.	15 minutes in the morning post Baseline and CPAP studies
Secondary	Reactive Hyperemia Index (RHI)	The RHI is a measure of endothelial function that was measured in the morning after both Baseline and CPAP studies. It is unitless and scored on a range of 1 to 3 in healthy individuals with lower values indicating poor endothelial function.	15 minutes