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Hemodynamics Response to Upper Airway Obstruction in Marfan Syndrome
NA trial testing CPAP in Sleep-disordered Breathing in 31 participants. Completed in 6 December 2019.
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 6 June 2018 |
| Primary completion | 6 December 2019 |
| Estimated completion | 6 December 2019 |
| Sites | 1 location across United States |
Johns Hopkins University
18 and older, any sex, with Sleep-disordered Breathing or Snoring. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pleural pressure (Pes) in mmHg monitored using an esophageal catheter.
| Group | Value | 95% CI |
|---|---|---|
| Baseline Sleep Study | 9.3 | ± 3.4 |
| CPAP Sleep Study | 4.4 | ± 1.6 |
Continuous blood pressure monitored using a non-invasive finger cuff. Data captured in mmHg.
| Group | Value | 95% CI |
|---|---|---|
| Baseline Sleep Study | 93.8 | ± 14.0 |
| CPAP Sleep Study | 88.3 | ± 12.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Baseline Sleep Study | 11.0 | ± 3.8 |
| CPAP Sleep Study | 2.4 | ± 3.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Baseline Sleep Study | 2.2 | ± 0.1 |
| CPAP Sleep Study | 2.2 | ± 0.2 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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