CPAP for Supine Hypertension

Recruiting in Palo Alto (17 mi)

Overseen by Italo Biaggioni, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Heart failure, Coronary artery disease, others

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.

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 data supports the effectiveness of the treatment 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 hypertension. In patients with OSA, CPAP has been effective in reducing blood pressure, which could decrease the risk of heart-related issues. ^{1 2 3 4 5}

Is CPAP generally safe for humans?

CPAP is generally considered safe for humans and is commonly used to treat conditions like obstructive sleep apnea. Studies have shown it can help reduce blood pressure, especially in patients with sleep apnea and hypertension, without significant safety concerns. ^{2 3 6 7 8}

How is CPAP treatment different for supine hypertension?

CPAP (Continuous Positive Airway Pressure) is unique for treating supine hypertension (high blood pressure when lying down) because it increases pressure in the chest, similar to a Valsalva maneuver, which can lower blood pressure without worsening orthostatic hypotension (low blood pressure when standing). This approach is novel as it addresses both nighttime high blood pressure and daytime low blood pressure in patients with autonomic failure. ^{2 3 4 9 10}

Research Team

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• continuous positive airway pressure (CPAP) (Other)

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.

Participant Groups

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 Canada for the following indications:

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+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

Findings from Research

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]

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 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]

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]

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 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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Use of continuous positive airway pressure for sleep apnea in the treatment of hypertension. [2021]

3. Netherlands 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Continuous Positive Airway Pressure for the Treatment of Supine Hypertension and Orthostatic Hypotension in Autonomic Failure. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Can nasal continuous positive airway pressure decrease clinic blood pressure in patients with obstructive sleep apnea? [2019]

6. England pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure on ambulatory blood pressure in patients with obstructive sleep apnoea. [2019]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Diagnostic and therapeutic approach to nonsleepy apnea. [2015]

9. Brazil 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. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Association between treated and untreated obstructive sleep apnea and risk of hypertension. [2023]