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CPAP for the Treatment of Supine Hypertension
NCT05489575 · Vanderbilt University Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Study design
Enrollment target: 59 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2022-06-23
Estimated completion: 2027-08-31
Last updated: 2026-04-07
Interventions
Device: Active CPAPDevice: Sham CPAPOther: Sleeping in a head-up tilt (HUT) position
Primary outcomes
- • Systolic blood pressure (daytime) (day 1 and 2 (within 2 hours of the intervention))
- • Systolic blood pressure (overnight) (up to 9 hours during the intervention)
Sponsor
Vanderbilt University Medical Center · other
With: National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactBonnie K Black, RN, NP · contact · bonnie.black@vumc.org · 615-343-6862
ContactLuis E Okamoto, MD · contact · luis.e.okamoto@vumc.org · 615-936-6119
InvestigatorItalo Biaggioni, MD · principal_investigator, Vanderbilt University Medical Center
All locations (1)
Autonomic Dysfunction Center/ Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States