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Positive Airway Pressure Device

CPAP for Supine Hypertension

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
Nocturnal supine hypertension (nighttime systolic blood pressure ≥140 mmHg) during the overnight screening for supine hypertension
Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and 2 (within 2 hours of the intervention)
Awards & highlights

Study Summary

This trial aims to learn if using CPAP can lower blood pressure for people with autonomic failure and high blood pressure when lying down.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly stated here, common side effects of using CPAP may include discomfort or irritation from the mask, dry nose or throat, nasal congestion, headaches and sometimes stomach bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood pressure at night is 140 mmHg or higher.
Select...
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.
Select...
I experience a significant drop in blood pressure when standing due to a nerve condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and 2 (within 2 hours of the intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and 2 (within 2 hours of the intervention) 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 (daytime)
Systolic blood pressure (overnight)
Secondary outcome measures
Morning orthostatic tolerance (overnight)
Natriuretic hormone (daytime)
Nocturnal diuresis (overnight)
+1 more

Side effects data

From 2008 Phase 3 trial • 1105 Patients • NCT00051363
37%
HEENT
24%
Respiratory
18%
Dermatological
9%
General
8%
Musculoskeletal
8%
Psychiatric
6%
GI / Digestive
6%
Neurological
5%
Cardiovascular
4%
Other Accident
2%
Genitourinary
2%
Motor Vehicle Accident (MVA)
1%
Endocrinological
1%
Near-miss MVA
1%
Hematologic / Lymphatic
1%
Work-related Accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active CPAP
Sham CPAP

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active CPAP (Overnight Study)Experimental Treatment1 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 Treatment1 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 Control1 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 Group1 Intervention
Sham CPAP is applied for up to 2 hours while supine and awake.
Group V: Sham CPAP (Overnight Study)Placebo Group1 Intervention
Sham CPAP is applied for up to 9 hours during the night.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active CPAP
2002
Completed Phase 3
~1110

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,133 Total Patients Enrolled
2 Trials studying Supine Hypertension
56 Patients Enrolled for Supine Hypertension
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,836 Total Patients Enrolled
Italo Biaggioni, MDPrincipal InvestigatorVanderbilt University Medical Center
28 Previous Clinical Trials
1,395 Total Patients Enrolled
2 Trials studying Supine Hypertension
56 Patients Enrolled for Supine Hypertension

Media Library

Active CPAP (Positive Airway Pressure Device) Clinical Trial Eligibility Overview. Trial Name: NCT05489575 — N/A
Supine Hypertension Research Study Groups: Active CPAP (Daytime Study), Sham CPAP (Daytime Study), Active CPAP (Overnight Study), Sham CPAP (Overnight Study), Sleeping in a head-up tilt position (Overnight Study)
Supine Hypertension Clinical Trial 2023: Active CPAP Highlights & Side Effects. Trial Name: NCT05489575 — N/A
Active CPAP (Positive Airway Pressure Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05489575 — N/A

Frequently Asked Questions

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

Are individuals with the specified criteria currently being recruited for this trial?

"The trial is still enrolling, as denoted by the data shown on clinicaltrials.gov; this medical experiment was first publicized on June 23rd 2022 and has had its information updated most recently on August 3rd of the same year."

Answered by AI

Are there any eligibility criteria for participation in this trial?

"This trial, which plans to enrol 59 participants, is seeking individuals aged 40-80 with autonomic failure."

Answered by AI

What are the intended outcomes of this research?

"The primary purpose of the 9 hour-long trial is to measure Systolic blood pressure in a daytime setting. Secondary objectives include Morning orthostatic tolerance, Natriuretic hormone levels, and Nocturnal diuresis during an overnight assessment period."

Answered by AI

Does this investigation accept participants of eighteen years or older?

"According to the criteria for trial participation, patients must be aged between 40 and 80 in order to join."

Answered by AI

What is the aggregate size of individuals enrolling in this research?

"Affirmative. Clinicaltrials.gov data indicates that this trial, first posted on June 23rd 2022, is presently recruiting participants from 1 medical centre with a goal of 59 recruits in total."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Hopefully they help myself and others.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Autonomic Dysfunction Center/ Vanderbilt University Medical Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
CPAP for the Treatment of Supine Hypertension
Italo Biaggioni 2022. "CPAP for the Treatment of Supine Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05489575.
All > Multiple System Atrophy
~29 spots leftby Mar 2026
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