Sleep-disordered BreathingMSBNCT03985657
Hemodynamics Response to Upper Airway Obstruction in Marfan Syndrome
A study testing CPAP in people with Sleep-disordered Breathing and Snoring, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep-disordered Breathing, Snoring
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2018to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People with Marfan syndrome.
- Age ≥ 18yrs
- Able and willing to provide informed consent
- Willing to sleep connected to research apparatus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Disordered Breathing in Marfan Syndrome: Susceptibility and Hemodynamics
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.
Read the detailed 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)
- Conditions
- Sleep-disordered Breathing, Snoring
- Being tested
- CPAP
- Medical subject headings
- Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Sleep Study | Active comparator | 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. Receives: Device: CPAP |
| CPAP Sleep Study | Experimental | 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. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural Pressure (Pes)
Pleural pressure (Pes) in mmHg monitored using an esophageal catheter.
Measured: 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.
Measured: Overnight on both Baseline and CPAP studies
Secondary outcomes (2)
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.
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start6 Jun 2018
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep-disordered BreathingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be assigned to a Baseline polysomnography and CPAP polysomnography in a randomized fashion. Participants will then be switched to the second polysomnography within 14 days of the first. The baseline polysomnography represents the exposure to sleep disordered breathing and the CPAP polysomnography represents the relief of the exposure. Markers of hemodynamic stress will be assessed in the morning after both studies.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The Marfan Foundation, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Mudiaga Sowho, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985657
- Sponsor's protocol ID
- IRB00157403
- Acronym
- MSB
- Status last verified
- Dec 2020
- First submitted
- 11 Jun 2019
- Last updated
- 28 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing in Marfan Syndrome: Susceptibility and Hemodynamics
- ClinicalTrials.gov ID
- NCT03985657
- Acronym / sponsor ID
- MSB / IRB00157403
- Conditions
- Sleep-disordered Breathing, Snoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The Marfan Foundation, National Institutes of Health (NIH)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Posted 28 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to a Baseline polysomnography and CPAP polysomnography in a randomized fashion. Participants will then be switched to the second polysomnography within 14 days of the first. The baseline polysomnography represents the exposure to sleep disordered breathing and the CPAP polysomnography represents the relief of the exposure. Markers of hemodynamic stress will be assessed in the morning after both studies.
| Arm | Type | Receives |
|---|---|---|
| Baseline Sleep Study | Active comparator | Device: CPAPBaseline 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. |
| CPAP Sleep Study | Experimental | Device: CPAPParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People with Marfan syndrome.
- Age ≥ 18yrs
- Able and willing to provide informed consent
- Willing to sleep connected to research apparatus
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPContinuous positive airway pressure (CPAP). Room air at pressures between 6-8 centimeters of water (cmH2O) delivered via heated humidified tubing and a nasal mask. | Device | Baseline Sleep Study, CPAP Sleep Study |
Primary outcome
Pleural Pressure (Pes)
Time frame: Overnight on both CPAP and No CPAP nights
Pleural pressure (Pes) in mmHg monitored using an esophageal catheter.
Mean Arterial Blood Pressure (MAP)
Time frame: Overnight on both Baseline and CPAP studies
Continuous blood pressure monitored using a non-invasive finger cuff. Data captured in mmHg.
2 secondary outcomes
Augmentation Index (AI)
Time frame: 15 minutes in the morning post Baseline and CPAP studies
Reactive Hyperemia Index (RHI)
Time frame: 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mudiaga Sowho principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Sleep-disordered Breathing and Snoring, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleural Pressure (Pes) (time frame: Overnight on both CPAP and No CPAP nights). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.