CPAP for Supine Hypertension

Overseen By Cyndya A Shibao, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Recent facial trauma, Bedridden, Smokers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

59 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how continuous positive airway pressure (CPAP) can assist people with autonomic failure who experience high blood pressure when lying down. CPAP, commonly used for sleep apnea, involves a machine that provides a steady airflow through a mask to keep airways open. The trial tests CPAP effects both during the day and overnight, comparing it to a sham CPAP and sleeping with the bed slightly tilted. It seeks participants aged 40-80 who have been diagnosed with autonomic failure and experience high blood pressure at night. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance treatment options for autonomic failure.

Will I have to stop taking my current medications?

The trial mentions a medication withdrawal period, so you may need to stop taking some of your current medications. However, it is not clear which specific medications this applies to.

What prior data suggests that CPAP is safe for treating supine hypertension?

Research shows that CPAP (Continuous Positive Airway Pressure) is generally safe for most people. CPAP often treats sleep apnea, a condition where breathing stops and starts during sleep. Studies indicate that CPAP can help lower blood pressure in people with high blood pressure, even when lying down, known as supine hypertension. This suggests CPAP might be helpful and well-tolerated for this condition too.

Research also shows that sleeping with the head raised can safely lower blood pressure when lying down by using gravity to reduce blood flow back to the heart. This method manages conditions like orthostatic hypotension, where blood pressure drops when standing up.

Both CPAP and sleeping with the head raised are considered safe, with few reports of serious side effects. However, individual experiences can vary, so consulting a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage supine hypertension. Unlike traditional hypertension treatments that primarily involve medication, this study examines the use of CPAP (Continuous Positive Airway Pressure) and positional therapy. CPAP is applied at different pressures during both daytime and overnight periods, offering a non-drug approach to potentially lower blood pressure. Additionally, the trial investigates whether sleeping in a head-up tilt position can effectively manage hypertension, providing a simple and accessible alternative to medication. These approaches could lead to new, non-pharmacological methods for controlling blood pressure, expanding treatment options for patients.

What evidence suggests that CPAP could be effective for supine hypertension?

Research has shown that CPAP (a machine that aids breathing during sleep) can lower blood pressure in individuals with high blood pressure while lying down, particularly at night. In this trial, participants may receive Active CPAP, which helps control blood pressure in those with both sleep apnea and this type of high blood pressure by keeping the airway open and preventing changes in blood pressure during sleep. Another treatment arm involves sleeping in a head-up tilt position, which has been shown to reduce nighttime high blood pressure. This position uses gravity to decrease blood flow to the heart, helping to lower blood pressure when lying down. The trial tests both methods for their effectiveness in managing high blood pressure at night. ^{4 6 7 8 9}

Who Is on the Research Team?

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with autonomic failure conditions like multiple system atrophy or Parkinson's disease, who experience a significant drop in blood pressure upon standing and high blood pressure when lying down. Excluded are those intolerant to CPAP, unable to stand, recent smokers, pregnant women, or individuals with unstable heart disease.

Inclusion Criteria

My blood pressure at night is 140 mmHg or higher.

I am between 40 and 80 years old with a diagnosis of autonomic failure, including conditions like pure autonomic failure, multiple system atrophy, or Parkinson's disease.

I experience a significant drop in blood pressure when standing due to a nerve condition.

Exclusion Criteria

I am bedridden or cannot stand due to severe weakness or dizziness.

I cannot stand for at least one minute or have very high blood pressure after stopping my medication.

You are a smoker, pregnant, have unstable heart disease, recent major heart or brain problems, heart failure, or other health issues that could make it hard to complete the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Daytime Study

Participants undergo two study days with active and sham CPAP applied for up to 2 hours each day

2 days

2 visits (in-person)

Overnight Study

Participants undergo three study nights with active CPAP, sham CPAP, and head-up tilt position applied for up to 9 hours each night

3 nights

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Active CPAP
• Sham CPAP
• Sleeping in a head-up tilt (HUT) position

Trial Overview

The study tests if continuous positive airway pressure (CPAP) can treat nighttime high blood pressure in patients with autonomic failure. Participants will undergo active CPAP, sham CPAP (placebo), and sleep with the bed tilted head-up during separate sessions at Vanderbilt Clinical Research Center.

How Is the Trial Designed?

Group I: Active CPAP (Overnight Study) Experimental Treatment 1 Intervention

CPAP at 8, 10, or 12 cm H2O is applied for up to 9 hours during the night.

Group II: Active CPAP (Daytime Study) Experimental Treatment 1 Intervention

CPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake.

Group III: Sleeping in a head-up tilt position (Overnight Study) Active Control 1 Intervention

Sleeping with the bed tilted head-up by 10 degrees for up to 9 hours during the night.

Group IV: Sham CPAP (Daytime Study) Placebo Group 1 Intervention

Sham CPAP is applied for up to 2 hours while supine and awake.

Group V: Sham CPAP (Overnight Study) Placebo Group 1 Intervention

Sham CPAP is applied for up to 9 hours during the night.

Active CPAP is already approved in United States, European Union, Canada for the following indications:

Approved in United States as CPAP for:

• Sleep Apnea
• Supine Hypertension
• Autonomic Failure

Approved in European Union as CPAP for:

• Sleep Apnea
• Respiratory Failure
• Obstructive Sleep Apnea Syndrome

Approved in Canada as CPAP for:

• Sleep Apnea
• Respiratory Failure

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 60 patients with difficult-to-control hypertension and sleep apnea, CPAP treatment significantly reduced systolic blood pressure by an average of 5.2 mmHg, especially during nighttime, where it decreased by 6.1 mmHg.

CPAP treatment also improved the nocturnal blood pressure pattern, with a notable increase in the percentage of patients achieving a normal 'dipper' pattern from 9.1% to 36.4%, indicating better blood pressure regulation during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive effect of CPAP treatment on the control of difficult-to-treat hypertension. Martínez-García, MA., Gómez-Aldaraví, R., Soler-Cataluña, JJ., et al.[2022]

In a study involving 26 patients with autonomic failure, increasing levels of continuous positive airway pressure (CPAP) significantly reduced systolic blood pressure in a dose-dependent manner, demonstrating its potential to treat supine hypertension.

In a follow-up study with 11 patients, overnight CPAP therapy effectively lowered nighttime blood pressure and reduced nocturnal diuresis, while also improving daytime orthostatic hypotension, suggesting it is a safe and effective nonpharmacologic treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Positive Airway Pressure for the Treatment of Supine Hypertension and Orthostatic Hypotension in Autonomic Failure. Okamoto, LE., Celedonio, JE., Smith, EC., et al.[2023]

In a study of 131 normotensive patients with obstructive sleep apnea, 6 months of CPAP treatment led to a statistically significant reduction in mean 24-hour diastolic blood pressure (DBP) and overall ambulatory blood pressure, particularly in those with masked hypertension.

The results indicate that CPAP may have varying effects on blood pressure depending on the presence of undiagnosed masked hypertension and the patient's circadian blood pressure pattern, highlighting the importance of 24-hour ambulatory blood pressure monitoring in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normotensive patients with obstructive sleep apnoea: changes in 24-h ambulatory blood pressure monitoring with continuous positive airway pressure treatment. Sapiña-Beltrán, E., Santamaria-Martos, F., Benítez, I., et al.[2023]

Continuous positive airway pressure (CPAP) significantly reduces blood pressure in patients with systemic hypertension and obstructive sleep apnea, with notable decreases in both systolic and diastolic blood pressure across various times of day, based on a meta-analysis of 19 trials involving 1904 participants.

The effectiveness of CPAP in lowering blood pressure is particularly evident with follow-up periods of 3 months or longer, indicating that longer treatment durations may be necessary to achieve optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of continuous positive airway pressure on blood pressure in patients with hypertension and obstructive sleep apnea: a meta-analysis. Shang, W., Zhang, Y., Liu, L., et al.[2022]

In a study involving 340 patients with newly diagnosed systemic hypertension and obstructive sleep apnea, continuous positive airway pressure (CPAP) therapy led to a statistically significant reduction in 24-hour ambulatory blood pressure by an average of 1.5 mm Hg compared to a placebo after three months.

While the reduction in blood pressure was small and did not meet the target of 3 mm Hg, the findings suggest that even minimal decreases in blood pressure could be beneficial for patients with hypertension, considering the high prevalence of the condition and associated health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure as treatment for systemic hypertension in people with obstructive sleep apnoea: randomised controlled trial. Durán-Cantolla, J., Aizpuru, F., Montserrat, JM., et al.[2022]

In a study of 1889 participants over a median follow-up of 12.2 years, those with obstructive sleep apnea (OSA) had a higher risk of developing hypertension compared to those without OSA.

However, patients with OSA who adhered to continuous positive airway pressure (CPAP) therapy had a significantly lower risk of developing hypertension, suggesting that CPAP treatment is effective in reducing this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between treated and untreated obstructive sleep apnea and risk of hypertension. Marin, JM., Agusti, A., Villar, I., et al.[2023]

In a study of 30 hypertensive patients with Obstructive Sleep Apnoea Syndrome (OSAS) treated with Positive Airway Pressure (PAP), an unexpected rise in blood pressure was observed after PAP usage, with mean increases of 16 mmHg in mean blood pressure and 20 mmHg in systolic blood pressure.

No correlations were found between the increase in blood pressure and factors such as OSAS severity, PAP compliance, or body mass index, suggesting that the reasons for this paradoxical response to treatment remain unclear and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paradoxical reaction of blood pressure on sleep apnoea patients treated with Positive Airway Pressure. Chaves Loureiro, C., Drummond, M., Winck, JC., et al.[2019]

Continuous positive airway pressure (CPAP) therapy can improve blood pressure in hypertensive patients with obstructive sleep apnea (OSA), but the effect is smaller compared to antihypertensive medications.

Patients with more severe OSA and better adherence to CPAP therapy experience greater benefits, and using CPAP alongside antihypertensive medications may enhance cardiovascular health by restoring normal blood pressure patterns and improving arterial stiffness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of continuous positive airway pressure for sleep apnea in the treatment of hypertension. Denker, MG., Cohen, DL.[2021]

In a study of 122 patients with obstructive sleep apnoea (OSA), CPAP therapy resulted in only a small and statistically insignificant reduction in blood pressure after 2 and 4 months, suggesting limited efficacy in lowering hypertension associated with OSA.

Despite a high prevalence of hypertension (77%) among participants, CPAP treatment did not significantly reduce this rate, indicating that patients with OSA may require additional antihypertensive treatment beyond CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure on ambulatory blood pressure in patients with obstructive sleep apnoea. Hermida, RC., Zamarrón, C., Ayala, DE., et al.[2019]

A systematic review of 16 randomized clinical trials involving 1166 patients with obstructive sleep apnea (OSA) found that continuous positive airway pressure (CPAP) therapy significantly reduced blood pressure, including a decrease in office systolic blood pressure by 3.20 mmHg and diastolic blood pressure by 2.87 mmHg.

While CPAP therapy showed beneficial effects on nighttime and overall 24-hour blood pressure, it did not significantly affect daytime blood pressure, indicating that while CPAP can help manage blood pressure in OSA patients, its effects may vary throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure reduces blood pressure in patients with obstructive sleep apnea; a systematic review and meta-analysis with 1000 patients. Schein, AS., Kerkhoff, AC., Coronel, CC., et al.[2022]

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