Autonomic FailureNCT05489575
CPAP for the Treatment of Supine Hypertension
A study testing Active CPAP and Sleeping in a head-up tilt (HUT) position in people with Autonomic Failure and Pure Autonomic Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study aims to learn about the effects of continuous positive airway pressure (CPAP) on people with autonomic failure and high blood pressure when lying down (supine hypertension) to determine if it can be used to treat their high blood pressure during the night. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy
- What is being tested?
- Active CPAP and Sleeping in a head-up tilt (HUT) position
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease.
- Neurogenic orthostatic hypotension, defined as a ≥20-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
- Nocturnal supine hypertension (nighttime systolic blood pressure ≥140 mmHg) during the overnight screening for supine hypertension.
- Patients who are willing and able to provide informed consent
Who cannot join
- Patients with history of recent facial trauma or surgery or intolerance to CPAP or to the CPAP mask.
- Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute or those with sustained supine blood pressure ≥180/110 mmHg after the medication withdrawal period.
- Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.
- Smokers, patients who are pregnant, or have clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months; heart failure; and other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical or laboratory testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Bonnie K Black, RN, NP, 615-343-6862, bonnie.black@vumc.org
Luis E Okamoto, MD, (615) 936-6119, luis.e.okamoto@vumc.org
About this study
Official title: Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension
This study aims to learn about the effects of continuous positive airway pressure (CPAP) on people with autonomic failure and high blood pressure when lying down (supine hypertension) to determine if it can be used to treat their high blood pressure during the night. CPAP (a widely used treatment for sleep apnea) involves using a machine that blows air into a tube connected to a mask covering the nose, or nose and mouth, to apply a low air pressure in the airways.
The study includes 3-5 days spent in the Vanderbilt Clinical Research Center (CRC): at least one day of screening tests, followed by up to 3 study days. Subjects may be able to participate in daytime and/or overnight studies. The Daytime study consists of 2 study days: one with active CPAP and one with sham CPAP applied for up to 2 hours. The Overnight study consists of 3 study nights: one with active CPAP, one with sham CPAP, both applied for up to 9 hours and one night sleeping with the bed tilted head-up.
Read the detailed description
The study includes up to 5 days spent in the Vanderbilt University Medical Center, at least one day of screening tests, followed by 2 study days and/or 2 study nights.
Screening tests include a physical examination and history, routine safety laboratory assessments, and autonomic nervous system testing. Medications for high blood pressure will be held for at least 5 half-lives before studies. Subjects may be able to participate in the daytime and/or the overnight studies.
Daytime Study:
Eligible participants will be studied on two separate days in random order: one day with a high CPAP level and one day with a low CPAP level. The active CPAP level will be determined during a CPAP titration trial
On each study day, participants will be instrumented to measure blood pressure, heart rate, hemodynamic parameters, segmental impedance, and markers of cardiovascular risk. A saline lock or IV catheter will be inserted in one of the arm's veins for blood sample collection. Urine will also be collected during studies.
After baseline measurements, active or sham CPAP will then be applied for up to 2 hours. Outcome measurements will be repeated after 1 and 2 hours of CPAP.
Overnight Studies:
Eligible participants will be studied on three separate nights in random order with a active CPAP, sham CPAP, and sleeping in a head-up tilt position. The active CPAP level will be determined during a CPAP titration trial.
On each study night, the intervention (active CPAP, sham CPAP, or head-up tilt position) will be applied for up to 9 hours. Blood pressure, heart rate, hemodynamic parameters, and markers of cardiovascular risk will be assessed throughout the night. Urine will also be collected during this period. On the following morning, participants will have a tilt table test.
- Conditions
- Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease, Supine Hypertension, Neurogenic Orthostatic Hypotension
- Being tested
- Active CPAP, Sham CPAP, Sleeping in a head-up tilt (HUT) position
- Keywords
- CPAP, Hypertension, Orthostatic hypotension
- Medical subject headings
- Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease, Hypertension, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CPAPDevice
Also called Active continuous positive airway pressure
Continuous positive airway pressure (CPAP) is applied at 8, 10, or 12 cm H20. The active CPAP level will be determined during a CPAP titration trial
Sham CPAPDevice
Also called Sham continuous positive airway pressure
Sham continuous positive airway pressure applied at <4 cm H2O
Sleeping in a head-up tilt (HUT) positionOther
Also called HUT sleeping
Sleeping with the whole bed tilted head-up by 10 degrees or with the head elevated by 13-14 inches.
| Study group | Role | What they receive |
|---|---|---|
| Active CPAP (Daytime Study) | Experimental | CPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake. Receives: Device: Active CPAP |
| Sham CPAP (Daytime Study) | Sham comparator | Sham CPAP is applied for up to 2 hours while supine and awake. Receives: Device: Sham CPAP |
| Active CPAP (Overnight Study) | Experimental | CPAP at 8, 10, or 12 cm H2O is applied for up to 9 hours during the night. Receives: Device: Active CPAP |
| Sham CPAP (Overnight Study) | Sham comparator | Sham CPAP is applied for up to 9 hours during the night. Receives: Device: Sham CPAP |
| Sleeping in a head-up tilt position (Overnight Study) | Active comparator | Sleeping with the bed tilted head-up by 10 degrees for up to 9 hours during the night. Receives: Other: Sleeping in a head-up tilt (HUT) position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (daytime)
Change from baseline in systolic blood pressure at 2 hours of the intervention
Measured: day 1 and 2 (within 2 hours of the intervention)
Systolic blood pressure (overnight)
Area under the curve of the change from baseline in systolic blood pressure
Measured: up to 9 hours during the intervention
Secondary outcomes (4)
Stroke Volume (daytime)
Change from baseline in stroke volume at 1and 2 hours of the intervention
Measured: day 1 and 2 (within 2 hours of the intervention)
Natriuretic hormone (daytime)
Percent change from baseline in N-terminal-proatrial natriuretic peptide at 2 hours after the intervention
Measured: day 1 and 2 (within 2 hours of the intervention)
Nocturnal diuresis (overnight)
Urine volume collected during the night
Measured: up to 9 hours during the intervention
Morning orthostatic tolerance (overnight)
Area under the curve of the upright systolic blood pressure during head-up tilt
Measured: during 10 minutes upright tilt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start23 Jun 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Randomized, single-blind, crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Italo Biaggioni, Vanderbilt University Medical Center
- Investigators
- Italo Biaggioni, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489575
- Sponsor's protocol ID
- 220821
- Other IDs
- R01HL161095, 200124
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT05489575
- Acronym / sponsor ID
- 220821
- Conditions
- Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease, Supine Hypertension, Neurogenic Orthostatic Hypotension
- Keywords
- CPAP, Hypertension, Orthostatic hypotension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to learn about the effects of continuous positive airway pressure (CPAP) on people with autonomic failure and high blood pressure when lying down (supine hypertension) to determine if it can be used to treat their high blood pressure during the night. CPAP (a widely used treatment for sleep apnea) involves using a machine that blows air into a tube connected to a mask covering the nose, or nose and mouth, to apply a low air pressure in the airways.
The study includes 3-5 days spent in the Vanderbilt Clinical Research Center (CRC): at least one day of screening tests, followed by up to 3 study days. Subjects may be able to participate in daytime and/or overnight studies. The Daytime study consists of 2 study days: one with active CPAP and one with sham CPAP applied for up to 2 hours. The Overnight study consists of 3 study nights: one with active CPAP, one with sham CPAP, both applied for up to 9 hours and one night sleeping with the bed tilted head-up.
Detailed description
The study includes up to 5 days spent in the Vanderbilt University Medical Center, at least one day of screening tests, followed by 2 study days and/or 2 study nights.
Screening tests include a physical examination and history, routine safety laboratory assessments, and autonomic nervous system testing. Medications for high blood pressure will be held for at least 5 half-lives before studies. Subjects may be able to participate in the daytime and/or the overnight studies.
Daytime Study:
Eligible participants will be studied on two separate days in random order: one day with a high CPAP level and one day with a low CPAP level. The active CPAP level will be determined during a CPAP titration trial
On each study day, participants will be instrumented to measure blood pressure, heart rate, hemodynamic parameters, segmental impedance, and markers of cardiovascular risk. A saline lock or IV catheter will be inserted in one of the arm's veins for blood sample collection. Urine will also be collected during studies.
After baseline measurements, active or sham CPAP will then be applied for up to 2 hours. Outcome measurements will be repeated after 1 and 2 hours of CPAP.
Overnight Studies:
Eligible participants will be studied on three separate nights in random order with a active CPAP, sham CPAP, and sleeping in a head-up tilt position. The active CPAP level will be determined during a CPAP titration trial.
On each study night, the intervention (active CPAP, sham CPAP, or head-up tilt position) will be applied for up to 9 hours. Blood pressure, heart rate, hemodynamic parameters, and markers of cardiovascular risk will be assessed throughout the night. Urine will also be collected during this period. On the following morning, participants will have a tilt table test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Randomized, single-blind, crossover
| Arm | Type | Receives |
|---|---|---|
| Active CPAP (Daytime Study) | Experimental | Device: Active CPAPCPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake. |
| Sham CPAP (Daytime Study) | Sham comparator | Device: Sham CPAPSham CPAP is applied for up to 2 hours while supine and awake. |
| Active CPAP (Overnight Study) | Experimental | Device: Active CPAPCPAP at 8, 10, or 12 cm H2O is applied for up to 9 hours during the night. |
| Sham CPAP (Overnight Study) | Sham comparator | Device: Sham CPAPSham CPAP is applied for up to 9 hours during the night. |
| Sleeping in a head-up tilt position (Overnight Study) | Active comparator | Other: Sleeping in a head-up tilt (HUT) positionSleeping with the bed tilted head-up by 10 degrees for up to 9 hours during the night. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease.
- Neurogenic orthostatic hypotension, defined as a ≥20-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
- Nocturnal supine hypertension (nighttime systolic blood pressure ≥140 mmHg) during the overnight screening for supine hypertension.
- Patients who are willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Patients with history of recent facial trauma or surgery or intolerance to CPAP or to the CPAP mask.
- Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute or those with sustained supine blood pressure ≥180/110 mmHg after the medication withdrawal period.
- Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.
- Smokers, patients who are pregnant, or have clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months; heart failure; and other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical or laboratory testing.
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 |
|---|---|---|
| Active CPAPAlso: Active continuous positive airway pressureContinuous positive airway pressure (CPAP) is applied at 8, 10, or 12 cm H20. The active CPAP level will be determined during a CPAP titration trial | Device | Active CPAP (Daytime Study), Active CPAP (Overnight Study) |
| Sham CPAPAlso: Sham continuous positive airway pressureSham continuous positive airway pressure applied at <4 cm H2O | Device | Sham CPAP (Daytime Study), Sham CPAP (Overnight Study) |
| Sleeping in a head-up tilt (HUT) positionAlso: HUT sleepingSleeping with the whole bed tilted head-up by 10 degrees or with the head elevated by 13-14 inches. | Other | Sleeping in a head-up tilt position (Overnight Study) |
Primary outcome
Systolic blood pressure (daytime)
Time frame: day 1 and 2 (within 2 hours of the intervention)
Change from baseline in systolic blood pressure at 2 hours of the intervention
Systolic blood pressure (overnight)
Time frame: up to 9 hours during the intervention
Area under the curve of the change from baseline in systolic blood pressure
4 secondary outcomes
Stroke Volume (daytime)
Time frame: day 1 and 2 (within 2 hours of the intervention)
Natriuretic hormone (daytime)
Time frame: day 1 and 2 (within 2 hours of the intervention)
Nocturnal diuresis (overnight)
Time frame: up to 9 hours during the intervention
Morning orthostatic tolerance (overnight)
Time frame: during 10 minutes upright tilt
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- 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.
Italo Biaggioni, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active CPAP and Sleeping in a head-up tilt (HUT) position in people with Autonomic Failure and Pure Autonomic Failure, run by Vanderbilt University Medical Center 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 4 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bonnie K Black, RN, NP (615-343-6862, bonnie.black@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (daytime) (time frame: day 1 and 2 (within 2 hours of the intervention)). 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 7 Apr 2026.