CPAP for Supine Hypertension

Overseen By Luis E Okamoto, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Heart failure, Coronary artery disease, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 hours

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using continuous positive airway pressure (CPAP) at night can lower high blood pressure when lying down, a common issue in people with autonomic failure. Autonomic failure disrupts the body's ability to control blood pressure and can cause complications when standing. The trial compares CPAP use to a placebo, such as a pill or sham CPAP. Individuals with autonomic failure and high blood pressure when lying down, but without a history of serious heart or liver issues, may be suitable for this trial. As an unphased trial, it offers a unique opportunity to advance understanding of new treatment options for autonomic failure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that using a CPAP machine can effectively treat high blood pressure when lying down in people with autonomic failure. Earlier studies found that CPAP lowers blood pressure without medication. This is significant because CPAP can help without the side effects that medicines might cause.

Most people find CPAP easy to use. It is often used for sleep apnea, a condition where breathing stops and starts during sleep. Due to its widespread use for sleep apnea, extensive safety information is available. Many people use CPAP machines nightly without major problems.

While CPAP can sometimes cause a dry nose or throat, or slight discomfort from wearing the mask, these effects are usually mild. Overall, CPAP is considered safe and offers a non-drug option that might help manage blood pressure during sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using continuous positive airway pressure (CPAP) for supine hypertension because it offers a unique non-pharmacological approach. Unlike traditional medications that manage blood pressure through chemical means, CPAP works by mechanically keeping the airways open during sleep, which may help reduce elevated blood pressure when lying down. This method could offer a novel way to address supine hypertension, potentially benefiting those who experience side effects from medication or prefer non-drug interventions. Additionally, CPAP's established use for sleep apnea makes it a familiar and accessible option for many patients.

What evidence suggests that CPAP is effective for supine hypertension?

Research has shown that using a continuous positive airway pressure (CPAP) machine can help lower blood pressure in some individuals. In this trial, participants will receive either CPAP or a placebo treatment, such as a placebo pill, patch, or sham CPAP. CPAP, a non-drug treatment, can manage high blood pressure when lying down, particularly in those with autonomic failure. It can also address issues like frequent nighttime urination and dizziness or lightheadedness when standing. Studies on individuals with obstructive sleep apnea, a condition where breathing stops and starts during sleep, indicate that CPAP can reduce blood pressure. This suggests it might also help with high blood pressure when lying down. Overall, CPAP offers a promising approach to managing blood pressure in affected individuals. ^{1 2 3 4 6}

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 patients with autonomic failure who also have high blood pressure when lying down. It's open to all races but not for medical students, pregnant women, or those at high risk like heart failure, serious coronary issues, liver problems, or a history of stroke or heart attack. People with severe allergies or asthma can't join.

Inclusion Criteria

You have a condition called autonomic failure and high blood pressure when lying down.

Exclusion Criteria

History of serious allergies or asthma.

I have a history of serious heart, liver conditions, or stroke.

All medical students

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continuous positive airway pressure (CPAP) treatment during the night to assess its effect on supine hypertension

12 hours

1 visit (in-person) for initial setup and monitoring

Follow-up

Participants are monitored for changes in supine systolic blood pressure and nocturnal urinary volume

12 hours

What Are the Treatments Tested in This Trial?

Interventions

• continuous positive airway pressure (CPAP)

Trial Overview The study is testing if using continuous positive airway pressure (CPAP) can lower blood pressure in people who experience higher blood pressure while lying down due to autonomic failure. A CPAP machine helps breathing and might affect blood pressure.

How Is the Trial Designed?

Group I: CPAP (continuous positive airway pressure) Active Control 1 Intervention

Continuous positive airway pressure during the night

Group II: Placebo pill or patch or sham CPAP Placebo Group 1 Intervention

Placebo pill or patch or sham CPAP

continuous positive airway pressure (CPAP) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as CPAP for:

• Obstructive Sleep Apnea
• Supine Hypertension in Autonomic Failure (investigational)

Approved in European Union as CPAP for:

• Obstructive Sleep Apnea
• Supine Hypertension in Autonomic Failure (investigational)

Approved in Canada as CPAP for:

• Obstructive Sleep Apnea
• Supine Hypertension in Autonomic Failure (investigational)

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Continuous positive airway pressure (CPAP) therapy significantly lowers both systolic and diastolic blood pressure in patients with resistant hypertension and obstructive sleep apnea, with reductions of -5.40 mmHg and -3.86 mmHg, respectively, based on a meta-analysis of six randomized controlled trials.

The analysis included 24-hour ambulatory blood pressure monitoring, confirming the efficacy of CPAP in managing blood pressure in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of continuous positive airway pressure on blood pressure in patients with resistant hypertension and obstructive sleep apnea: a systematic review and meta-analysis of six randomized controlled trials. Lei, Q., Lv, Y., Li, K., et al.[2018]

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]

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]

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 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]

Continuous positive airway pressure (CPAP) therapy can help reduce blood pressure in patients with severe obstructive sleep apnea, potentially mitigating cardiovascular risks associated with sleep-disordered breathing.

Recent studies indicate that patients with nonsleepy obstructive sleep apnea may not experience the same blood pressure reductions with CPAP, suggesting they might be less affected by the cardiovascular consequences of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic and therapeutic approach to nonsleepy apnea. Montserrat, JM., Garcia-Rio, F., Barbe, F.[2015]

In a study of 46 patients with moderate to severe obstructive sleep apnea (OSA), those with hypertension experienced a significant reduction in blood pressure after one year of treatment with nasal continuous positive airway pressure (CPAP).

The findings suggest that nasal CPAP can effectively lower blood pressure in hypertensive patients with OSA, potentially reducing the risk of cardiovascular complications, even in patients not taking anti-hypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can nasal continuous positive airway pressure decrease clinic blood pressure in patients with obstructive sleep apnea? Tun, Y., Hida, W., Okabe, S., et al.[2019]

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]

In a long-term study of 73 patients with uncontrolled hypertension, coronary heart disease, and obstructive sleep apnea, continuous positive airway pressure (CPAP) significantly reduced daytime systolic blood pressure (SBP) by 4 mm Hg and improved hypertension control compared to a control group.

CPAP users also experienced a notable decrease in daytime sleepiness, as measured by the Epworth Sleepiness Scale, indicating improved quality of life, while the trend in severe cardiovascular and cerebrovascular events was lower in the CPAP group compared to controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of continuous positive airway pressure on blood pressure and prognosis in hypertensive patients with coronary heart disease and obstructive sleep apnea: a randomized controlled trial. Huang, Z., Liu, Z., Luo, Q., et al.[2022]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.20081

Continuous Positive Airway Pressure for the Treatment of ... CPAP is a novel nonpharmacologic approach to treat the supine hypertension of autonomic failure while improving nocturia and daytime OH.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36601916/

Continuous Positive Airway Pressure for the Treatment of ... CPAP is a novel nonpharmacologic approach to treat the supine hypertension of autonomic failure while improving nocturia and daytime OH.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03312556

Treatment of Supine Hypertension in Autonomic Failure ... The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine ...

4. withpower.com withpower.com/trial/phase-pure-autonomic-failure-8-2017-5ce44

CPAP for Supine Hypertension Research shows that CPAP can lower blood pressure in patients with obstructive sleep apnea (OSA) and hypertension, suggesting it might also help with supine ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05489575

CPAP for the Treatment of Supine Hypertension CPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake. Intervention/Treatment, Device : Active CPAP. Continuous positive airway ...

6. ahajournals.org ahajournals.org/doi/10.1161/hyp.72.suppl_1.103

Abstract 103: Acute, Dose-Dependent, Blood Pressure ... We conclude that, in AF patients with supine hypertension, CPAP acutely decreases SBP in a dose-dependent manner, due to decreases in CO and SV ...