Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03312556
Status
Recruiting
Apply to this trial

Conditions

  • Autonomic Failure
  • Supine Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • continuous positive airway pressure (CPAP) — DEVICE
    Continuous positive airway pressure(CPAP) will be applied during the night starting from 20:00. CPAP level will be determined during an acute CPAP trial.
  • Placebo — DRUG
    Placebo pill or patch. Single dose

Study Details

Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.

Key Dates

Start date
Sep 21, 2017
Status verified
Nov 2025
Primary completion
Sep 21, 2026
Completion
Dec 21, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo pill or patch or sham CPAP
    Placebo pill or patch or sham CPAP
  • Active Comparator: CPAP (continuous positive airway pressure)
    Continuous positive airway pressure during the night

Primary Outcome Measure

Supine Systolic Blood Pressure [ Time Frame: 12 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Autonomic Dysfunction Center/ Vanderbilt University Medical CenterNashvilleTennessee37232
Emily C Smith, RN
[email protected]
615-875-1516
Bonnie K Black, RN
[email protected]
615-343-6862
Bonnie K Black, RN (SUB_INVESTIGATOR)
Luis E Okamoto, MD (SUB_INVESTIGATOR)
David Robertson, MD (SUB_INVESTIGATOR)
Italo Biaggioni, MD (PRINCIPAL_INVESTIGATOR)
Alfredo Gamboa, MD (SUB_INVESTIGATOR)
Cyndya A Shibao, MD (SUB_INVESTIGATOR)
Andre Diedrich, MD, PhD (SUB_INVESTIGATOR)
jorge Celedonio, MD (SUB_INVESTIGATOR)

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By research site
Autonomic Dysfunction Center/ Vanderbilt University Medical Center· Nashville, TN

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