Raised Head of Bed for Autonomic Failure

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 hour per session

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a simple, non-drug method to help individuals with autonomic failure who often experience high blood pressure when lying down. The study examines whether raising the head of the bed (known as Tilted Bed Therapy or Elevated Head of Bed Therapy) can lower this type of blood pressure by reducing the blood returning to the heart through gravity. Participants will try different bed elevation methods to determine which works best. This trial suits those with autonomic failure who frequently encounter high blood pressure while lying flat. As an unphased trial, it offers a unique opportunity to explore a non-drug treatment option that could enhance daily life for those affected.

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 raising the head of the bed is safe for treating supine hypertension?

Research has shown that raising the head of the bed can help lower high blood pressure in people with autonomic failure. This simple method involves tilting the bed so the head is higher than the feet. Studies have found that patients generally tolerate this well, and some even feel better when their beds are gradually inclined. The available research has reported no major side effects.

This trial is in the "Not Applicable" phase, focusing on exploring new ideas rather than testing a new drug. This indicates that the method's safety has been evaluated to some extent and is likely considered safe enough for further testing. Overall, raising the head of the bed appears to be a safe and easy way to help manage high blood pressure in certain conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a non-drug approach to managing autonomic failure, a condition often addressed with medications like fludrocortisone and midodrine. By simply elevating the head of the bed, this trial aims to assess if a change in sleeping position can help alleviate symptoms like blood pressure drops when standing. The different methods—using wedge pillows or tilting the entire bed—offer flexibility and might improve patient comfort and adherence. This approach is promising as it could present a low-cost, non-invasive alternative to current treatments, potentially reducing reliance on medications and their side effects.

What evidence suggests that raising the head of the bed is effective for supine hypertension?

Research has shown that raising the head of the bed can help lower blood pressure when lying down. This trial will explore different elevation methods, including raising the head of the bed by 8, 9, or 12 inches. Known as head-up tilt sleeping, this method reduces high blood pressure when lying flat by decreasing the amount of blood returning to the heart. Gravity helps prevent some blood from flowing back to the heart, which can lower blood pressure. People who have tried this method report feeling better with symptoms related to low blood pressure when standing. Some personal accounts also suggest it might slightly help with dizziness upon standing. ^{1 2 3 5 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 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

All medical students

History of serious allergies or asthma.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Raised Head of the Bed

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Tilt table conditioning significantly improved the condition of a patient with severe orthostatic hypotension, allowing him to walk after a three-week program, despite initial inability to sit.

While the patient was sensitive to pressor drugs, these alone did not stabilize his blood pressure; the combination of drug therapy and tilt table exercises proved effective, suggesting that this conditioning could be a valuable addition to treatment for similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of orthostatic hypotension: interaction of pressor drugs and tilt table conditioning. Hoeldtke, RD., Cavanaugh, ST., Hughes, JD.[2013]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04502225

Effect of Raised Head of the Bed on Lying Blood Pressure ... This study is exploring the impact of decreased venous return to the heart (achieved by raising the head of the bed) to lessen supine blood pressure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11521494/

Head-Up Tilt Sleeping to Treat Orthostatic Intolerance in a ... One method that has been hypothesised to positively affect OH is sleeping with the head of the bed elevated: head-up tilt sleeping (HUTS).

3. withpower.com withpower.com/trial/phase-pure-autonomic-failure-7-2020-e0109

Raised Head of Bed for Autonomic Failure This method significantly reduced the time needed to reach an upright position compared to traditional training methods, with 90.52% of patients completing the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10452159/

The Impact of Head-Up Tilt Sleeping on Orthostatic Tolerance Despite this, the anecdotal evidence suggested that HUTS therapy could slightly improve low standing blood pressure and its associated symptoms.

5. researchgate.net researchgate.net/publication/49753629_The_effect_of_sleeping_with_the_head_of_the_bed_elevated_six_inches_on_elderly_patients_with_orthostatic_hypotension_An_open_randomised_controlled_trial

The effect of sleeping with the head of the bed elevated six ... Effective treatment involves interpreting the results of autonomic function tests, which can lead to improvements in orthostatic dizziness ...

6. researchgate.net researchgate.net/publication/384124107_Head-up_Tilt_Sleeping_to_Treat_Orthostatic_Intolerance_in_a_Patient_with_Advanced_Parkinson's_Disease_A_Case_Report

(PDF) Head-Up Tilt Sleeping to Treat Orthostatic ... The patient noted a marked improvement of the orthostatic intolerance after a period in which he slowly step-by-step inclined the bed to an ...