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Raised Head of Bed for Autonomic Failure

N/A
Recruiting
Led By Italo Biaggioni, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 pm to 8 am or acute session (1 hour at each elevation of the head)
Awards & highlights

Study Summary

This trial is exploring whether raising the head of the bed may help to lower blood pressure for people with autonomic failure.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves physical adjustments rather than medication, side effects may include discomfort from sleeping at an incline or potential muscle strain but are expected to be minimal compared to drug therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 pm to 8 am
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 pm to 8 am for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Systolic Blood Pressure
Secondary outcome measures
Overnight Urine Volume

Trial Design

4Treatment groups
Experimental Treatment
Group I: Elevation of the whole bed (tilt) - In homeExperimental Treatment1 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 Treatment1 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 homeExperimental Treatment1 Intervention
Elevation of the trunk by raising the head 8 inches on a wedge pillow.
Group IV: Elevation of the trunkExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,149 Total Patients Enrolled
2 Trials studying Supine Hypertension
71 Patients Enrolled for Supine Hypertension
Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
28 Previous Clinical Trials
1,410 Total Patients Enrolled
2 Trials studying Supine Hypertension
71 Patients Enrolled for Supine Hypertension

Media Library

Raised Head of the Bed Clinical Trial Eligibility Overview. Trial Name: NCT04502225 — N/A
Supine Hypertension Research Study Groups: Elevation of the trunk - In home, Elevation of the trunk, Elevation of the whole bed (tilt), Elevation of the whole bed (tilt) - In home
Supine Hypertension Clinical Trial 2023: Raised Head of the Bed Highlights & Side Effects. Trial Name: NCT04502225 — N/A
Raised Head of the Bed 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502225 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the quota for individuals participating in this experiment?

"Yes, according to the clinicaltrials.gov portal, this medical research is looking for participants. It was first announced on August 21st 2020 and has recently been updated as of August 21st 2022. 44 individuals are needed between 1 site in order to complete the study's objectives."

Answered by AI

Who meets the eligibility criteria to participate in this research experiment?

"This study is targeting 44 individuals with supine hypertension, aged 18 to 85. Essential requirements for eligibility include being both male and female between the ages of majority and octogenarianism."

Answered by AI

Are individuals under the age of seventy permissible to take part in this clinical experiment?

"This medical trial is open to individuals aged 18 and over, but no older than 85."

Answered by AI

Are there any open recruitment opportunities for this investigation?

"Yes, according to clinicaltrials.gov records this trial is recruiting now. Initially posted on August 21st 2020 and recently updated on the same date one year later, 44 participants are being sought from a single medical facility."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Aug 2024