Raised Head of Bed for Autonomic Failure

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if lifting the head of the bed can help lower high blood pressure in patients with autonomic failure. These patients often have high blood pressure when lying down, which can worsen their condition. By raising the head of the bed, gravity helps keep some blood in the lower body, reducing the amount that returns to the heart and potentially lowering blood pressure.

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.

Is it safe to sleep with the head of the bed elevated?

Sleeping with the head of the bed elevated has been studied in young healthy volunteers and is generally considered safe, though the evidence supporting its benefits is weak. ^{1 2 3 4 5}

How is the Raised Head of Bed treatment different from other treatments for autonomic failure?

The Raised Head of Bed treatment is unique because it involves a non-drug approach of elevating the head of the bed to manage symptoms of autonomic failure, particularly orthostatic hypotension (a drop in blood pressure when standing up). This method contrasts with other treatments that often rely on medications or compression garments. ^{1 3 6 7 8}

Research Team

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adults aged 18-85 with autonomic failure who experience high blood pressure when lying down. It's open to all races and genders. Medical students, pregnant women, those at high risk (like heart failure or stroke), or with serious allergies/asthma cannot participate.

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 undergo elevation of the trunk or whole bed to assess impact on supine blood pressure

1 hour per session

Multiple sessions (in-home)

Follow-up

Participants are monitored for changes in blood pressure and urine volume after treatment

1 week

Treatment Details

Interventions

• Raised Head of the Bed (Behavioural Intervention)

Trial Overview The study tests if raising the head of the bed can lower blood pressure in patients with autonomic failure by reducing the amount of blood returning to the heart due to gravity. This non-drug approach could be a new way to treat supine hypertension.

Participant Groups

Group I: Elevation of the whole bed (tilt) - In home Experimental Treatment 1 Intervention

Tilt of the whole bed so that the participant's head is raised by 8 inches.

Group II: Elevation of the whole bed (tilt) Experimental Treatment 1 Intervention

Tilt of the whole bed so that the participant's head is raised by 9 and/or 12 inches.

Group III: Elevation of the trunk - In home Experimental Treatment 1 Intervention

Elevation of the trunk by raising the head 8 inches on a wedge pillow.

Group IV: Elevation of the trunk Experimental Treatment 1 Intervention

Elevation of the trunk by tilting just the head of the bed so that the participant's head is raised by 9 and/or 12 inches.

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 study of 91 acute stroke patients, autonomic dysfunction was found to be highly prevalent, with rates varying from 10% to 100% depending on the specific test used, and this dysfunction persisted even six months after the stroke.

The head-up tilt table test was safely administered, revealing that 10% of patients experienced orthostatic hypotension, and it can be a useful tool for assessing autonomic function in patients who can tolerate active standing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomic dysfunction after mild acute ischemic stroke and six months after: a prospective observational cohort study. Damkjær, M., Simonsen, SA., Heiberg, AV., et al.[2023]

Electric uprise bed training combined with a remote monitoring system is a safe and effective method for treating orthostatic hypotension (OH) in patients with spinal cord injury (SCI), with no severe symptoms reported during training in the experimental group of 36 patients.

This method significantly reduced the time needed to reach an upright position compared to traditional training methods, with 90.52% of patients completing the training successfully, indicating improved training efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical treatment of orthostatic hypotension after spinal cord injury with training based on electric uprise bed coupled with remote ECG and BP monitor. Shen, D., Huang, H., Yuan, H., et al.[2018]

In a study involving 29 healthy young volunteers, sleeping with the head of the bed tilted upwards (SHU) for one week significantly reduced the drop in systolic blood pressure when standing, indicating improved orthostatic tolerance.

SHU also led to fluid accumulation in the body, resulting in increased weight and ankle circumference, along with a decrease in nocturnal urinary volume, suggesting a potential antidiuretic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological effects of sleeping with the head of the bed elevated 18 in. in young healthy volunteers. Fan, CW., O'Sullivan, E., Healy, M., et al.[2018]

In a review of 142 pediatric patients referred for autonomic disorder testing, postural tachycardia syndrome was the most common diagnosis, affecting 71% of the patients, while orthostatic hypotension was rare at only 5%.

Testing was relevant to clinical symptoms in 88% of cases, and beta-blockers were the most frequently prescribed treatment, with 73% of patients reporting improvement, although the exact relationship between treatment and symptom relief remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric autonomic testing: retrospective review of a large series. Sukul, D., Chelimsky, TC., Chelimsky, G.[2012]

Pure autonomic failure is a degenerative disorder that leads to significant hypotension due to defects in norepinephrine release, causing patients to experience symptoms like fainting unless they sit or lie down.

Diagnosis is commonly established through tilt table testing or simple office tests, and treatment options include increasing fluid and salt intake, using compressive garments, and medications for more severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pure autonomic failure. Brown, TP.[2018]

Supine hypertension in patients with autonomic failure can lead to serious complications, and it is primarily managed by avoiding the supine position during the day and elevating the head of the bed at night.

Pharmacologic treatments like transdermal nitroglycerin and nifedipine are effective for managing this condition, but careful dose titration is necessary due to patients' heightened sensitivity to blood pressure-lowering medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of hypertension in the setting of autonomic dysfunction. Shibao, C., Gamboa, A., Diedrich, A., et al.[2020]

In a study involving 100 patients aged 60 and older with chronic orthostatic hypotension, the 6-inch tilt sleeping-head-up (SHU) position did not show any significant benefits in improving mean arterial pressure or other hemodynamic parameters compared to a control group over 6 weeks.

While both groups experienced similar improvements in symptoms, those using the SHU position were more likely to develop leg edema, suggesting that this method may not be safe or effective for older patients with orthostatic hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleeping with the head of the bed elevated six inches on elderly patients with orthostatic hypotension: an open randomised controlled trial. Fan, CW., Walsh, C., Cunningham, CJ.[2011]

References

1. England pubmed.ncbi.nlm.nih.gov

Autonomic dysfunction after mild acute ischemic stroke and six months after: a prospective observational cohort study. [2023]

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

Clinical treatment of orthostatic hypotension after spinal cord injury with training based on electric uprise bed coupled with remote ECG and BP monitor. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

Physiological effects of sleeping with the head of the bed elevated 18 in. in young healthy volunteers. [2018]

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

Treatment of orthostatic hypotension: interaction of pressor drugs and tilt table conditioning. [2013]

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

Pediatric autonomic testing: retrospective review of a large series. [2012]

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

Pure autonomic failure. [2018]

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

Management of hypertension in the setting of autonomic dysfunction. [2020]

8. England pubmed.ncbi.nlm.nih.gov

The effect of sleeping with the head of the bed elevated six inches on elderly patients with orthostatic hypotension: an open randomised controlled trial. [2011]