Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension

Plain English Summary

CPAP for the Treatment of Supine Hypertension is a Not Applicable clinical trial sponsored by Vanderbilt University Medical Center studying Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease, Supine Hypertension, Neurogenic Orthostatic Hypotension. This study tests if a CPAP machine, commonly used for sleep apnea, can help lower high blood pressure that occurs when lying down at night. It is for individuals aged 40-80 with autonomic failure, including conditions like Parkinson's disease, multiple system atrophy, or pure autonomic failure, who also experience high blood pressure when lying down and low blood pressure when standing up. Participation involves spending a few days at a research center for tests, including wearing a CPAP mask while sleeping, sometimes with a sham (inactive) device, and sleeping with the bed tilted. Alternatives may include managing medications, lifestyle changes, or other devices, but this study focuses on a specific CPAP approach for this condition. The trial aims to enroll 59 participants.

Official 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. 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 40 and 80 years old and have been diagnosed with autonomic failure (like Parkinson's or MSA) and experience high blood pressure when lying down and low blood pressure when standing. You cannot join if you have had recent facial injury or surgery, cannot tolerate CPAP masks, have severe intolerance to medication withdrawal, are bedridden, or have unstable heart or neurological conditions. Specific health requirements include having nighttime systolic blood pressure of 140 mmHg or higher when lying down and a significant drop in blood pressure upon standing. You must be willing and able to give informed consent to participate. This trial is studying Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease, Supine Hypertension, Neurogenic Orthostatic Hypotension, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures, systolic blood pressure during the day and night, will show if the CPAP device effectively reduces high blood pressure when lying down, which is a key symptom for these p The specific primary outcome measures are: 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a significant unmet need by investigating a non-pharmacological treatment for supine hypertension in patients with autonomic failure, potentially improving their quality of life a This research targets Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease, Supine Hypertension, Neurogenic Orthostatic Hypotension, where improved treatment options are needed.

Investor Insight

This trial signals a potential new therapeutic avenue for a niche but significant patient population, with CPAP being a readily available technology, suggesting a potentially favorable regulatory path

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of CPAP therapy for your condition and what to expect during the study. Be prepared for several days at a research center, including screening, wearing a mask connected to a machine while sleeping, and potentially sleeping with your bed tilted. Understand that you will be asked to stop certain medications temporarily as part of the study protocol. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: CROSSOVER
• Masking: SINGLE
• Enrollment: 59 participants

Interventions

• DEVICE: Active CPAP — 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
• DEVICE: Sham CPAP — Sham continuous positive airway pressure applied at \<4 cm H2O
• OTHER: Sleeping in a head-up tilt (HUT) position — Sleeping with the whole bed tilted head-up by 10 degrees or with the head elevated by 13-14 inches.

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)

Secondary Outcomes

• Stroke Volume (daytime) (day 1 and 2 (within 2 hours of the intervention))
• Natriuretic hormone (daytime) (day 1 and 2 (within 2 hours of the intervention))
• Nocturnal diuresis (overnight) (up to 9 hours during the intervention)
• Morning orthostatic tolerance (overnight) (during 10 minutes upright tilt)

Full 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.

Trial Locations

• Autonomic Dysfunction Center/ Vanderbilt University Medical Center, Nashville, Tennessee, United States

Frequently Asked Questions

Related Conditions

• Autonomic Failure
• Pure Autonomic Failure
• Multiple System Atrophy
• Parkinson Disease
• Supine Hypertension
• Neurogenic Orthostatic Hypotension
• Sleep Apnea
• Cardiovascular Disease
• Neurological Disorders
• Blood Pressure Regulation Disorders

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