CPAP for Supine Hypertension

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: Recent facial trauma, Bedridden, Smokers, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for supine hypertension?

Research shows that CPAP therapy, commonly used for obstructive sleep apnea, can help lower blood pressure in patients with both sleep apnea and hypertension. This suggests that CPAP might also be effective in managing supine hypertension, as it has been shown to reduce blood pressure in related conditions. ^{1 2 3 4 5}

Is CPAP therapy generally safe for humans?

The research on CPAP therapy, primarily used for conditions like obstructive sleep apnea and hypertension, suggests it is generally safe for humans. Studies have shown that CPAP can effectively reduce blood pressure without significant safety concerns. ^{1 3 4 6 7}

How does CPAP treatment for supine hypertension differ from other treatments?

CPAP (Continuous Positive Airway Pressure) is unique because it uses air pressure to keep airways open, which can lower blood pressure, especially at night, without medication. This is particularly beneficial for patients with supine hypertension (high blood pressure when lying down) and sleep apnea, as it can improve blood pressure control and reduce nighttime pressure spikes. ^{2 6 8 9 10}

Research Team

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Active CPAP (Positive Airway Pressure Device)
• Sham CPAP (Sham Device)
• Sleeping in a head-up tilt (HUT) position (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

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

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

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 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 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 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 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 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]

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. England pubmed.ncbi.nlm.nih.gov

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

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

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

3. 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]

4. 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]

5. Netherlands 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. [2022]

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

Positive effect of CPAP treatment on the control of difficult-to-treat hypertension. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure as treatment for systemic hypertension in people with obstructive sleep apnoea: randomised controlled trial. [2022]

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

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

9. Spain pubmed.ncbi.nlm.nih.gov

Paradoxical reaction of blood pressure on sleep apnoea patients treated with Positive Airway Pressure. [2019]

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

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