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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
Must not have
Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute or those with sustained supine blood pressure ≥180/110 mmHg after the medication withdrawal period
Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and 2 (within 2 hours of the intervention)

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot stand for at least one minute or have very high blood pressure after stopping my medication.
Select...
I am bedridden or cannot stand due to severe weakness or dizziness.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Systolic blood pressure (daytime)
Systolic blood pressure (overnight)
Secondary study objectives
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%
Motor Vehicle Accident (MVA)
2%
Genitourinary
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
906 Previous Clinical Trials
934,510 Total Patients Enrolled
9 Trials studying Multiple System Atrophy
271 Patients Enrolled for Multiple System Atrophy
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,884 Total Patients Enrolled
4 Trials studying Multiple System Atrophy
126 Patients Enrolled for Multiple System Atrophy
Italo Biaggioni, MDPrincipal InvestigatorVanderbilt University Medical Center
28 Previous Clinical Trials
1,395 Total Patients Enrolled
12 Trials studying Multiple System Atrophy
388 Patients Enrolled for Multiple System Atrophy

Media Library

Active CPAP (Positive Airway Pressure Device) Clinical Trial Eligibility Overview. Trial Name: NCT05489575 — N/A
Multiple System Atrophy 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)
Multiple System Atrophy 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
~19 spots leftby Mar 2026
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