An interventional study of CPAP in Sleep-disordered Breathing and Snoring, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-28.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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:
Secondary Outcomes:
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This study's enrollment of 31 is below the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
People with Marfan syndrome.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Baseline sleep polysomnography will involve the collection of electroencephalogram, electromyogram, electrocardiogram, airflow, heart rate, blood pressure, and pleural pressure during sleep with no CPAP. Participants in this arm would switch to CPAP within one week of the study.
Device: CPAP
Participants will be treated with continuous positive airway pressure to relieve sleep-disordered breathing. Participants in this arm would switch to Baseline study within one week of the study.
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.
Pleural Pressure (Pes)
Pleural pressure (Pes) in mmHg monitored using an esophageal catheter.
Time frame: Overnight on both CPAP and No CPAP nights
Mean Arterial Blood Pressure (MAP)
Continuous blood pressure monitored using a non-invasive finger cuff. Data captured in mmHg.
Time frame: Overnight on both Baseline and CPAP studies
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.
Time frame: 15 minutes in the morning post Baseline and CPAP studies
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.
Time frame: 15 minutes
193 persons with Marfan syndrome were screened. Persons were recruited from the Johns Hopkins Marfan Clinic and the external Marfan Community via the Marfan foundation. Inclusion was based on a clinical diagnosis of Marfan syndrome (Ghent Criteria) or genetic testing. Persons were excluded if they had any chronic lung disease, other sleep disorders aside from sleep apnea, were on blood thinners, or had uncontrolled blood pressure. Recruitment occurred between 09/2018 and 11/2019.
| Milestone | Baseline Sleep Study | CPAP Sleep Study |
|---|---|---|
| Started | 20 | 11 |
| Completed | 20 | 10 |
| Not completed | 0 | 1 |
| Milestone | Baseline Sleep Study | CPAP Sleep Study |
|---|---|---|
| Started | 20 | 10 |
| Completed | 20 | 10 |
| Not completed | 0 | 0 |
| Milestone | Baseline Sleep Study | CPAP Sleep Study |
|---|---|---|
| Started | 20 | 10 |
| Completed | 20 | 10 |
| Not completed | 0 | 0 |
Pleural pressure (Pes) in mmHg monitored using an esophageal catheter.
| mmHg | Baseline Sleep Study | CPAP Sleep Study |
|---|---|---|
| Pleural Pressure (Pes) | 9.3 ± 3.4 | 4.4 ± 1.6 |
Continuous blood pressure monitored using a non-invasive finger cuff. Data captured in mmHg.
| mmHg | Baseline Sleep Study | CPAP Sleep Study |
|---|---|---|
| Mean Arterial Blood Pressure (MAP) | 93.8 ± 14.0 | 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.
| percentage of pulse pressure | Baseline Sleep Study | CPAP Sleep Study |
|---|---|---|
| Augmentation Index (AI) | 11.0 ± 3.8 | 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.
| score on a scale | Baseline Sleep Study | CPAP Sleep Study |
|---|---|---|
| Reactive Hyperemia Index (RHI) | 2.2 ± 0.1 | 2.2 ± 0.2 |
Collected over Over the two night sessions.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baseline Sleep Study | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| CPAP Sleep Study | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 37.5 ± 15.9 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 17 |
| Male | 14 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 31 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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