CPAP for the Treatment of Supine Hypertension

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05489575
Status
Recruiting
Apply to this trial

Conditions

  • Autonomic Failure
  • Multiple System Atrophy
  • Neurogenic Orthostatic Hypotension
  • Parkinson Disease
  • Pure Autonomic Failure
  • Supine Hypertension

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Active CPAP — DEVICE
    Continuous positive airway pressure (CPAP) is applied at 8, 10, or 12 cm H20. The active CPAP level will be determined during a CPAP titration trial
  • Sham CPAP — DEVICE
    Sham continuous positive airway pressure applied at \<4 cm H2O
  • Sleeping in a head-up tilt (HUT) position — OTHER
    Sleeping with the whole bed tilted head-up by 10 degrees or with the head elevated by 13-14 inches.

Study Details

This study aims to learn about the effects of continuous positive airway pressure (CPAP) on people with autonomic failure and high blood pressure when lying down (supine hypertension) to determine if it can be used to treat their high blood pressure during the night. CPAP (a widely used treatment for sleep apnea) involves using a machine that blows air into a tube connected to a mask covering the nose, or nose and mouth, to apply a low air pressure in the airways. The study includes 3-5 days spent in the Vanderbilt Clinical Research Center (CRC): at least one day of screening tests, followed by up to 3 study days. Subjects may be able to participate in daytime and/or overnight studies. The Daytime study consists of 2 study days: one with active CPAP and one with sham CPAP applied for up to 2 hours. The Overnight study consists of 3 study nights: one with active CPAP, one with sham CPAP, both applied for up to 9 hours and one night sleeping with the bed tilted head-up.

Key Dates

Start date
Jun 23, 2022
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Aug 31, 2027

Study Design

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

Arms

  • Experimental: Active CPAP (Daytime Study)
    CPAP at 8, 10, or 12 cm H2O is applied for up to 2 hours while supine and awake.
  • Sham Comparator: Sham CPAP (Daytime Study)
    Sham CPAP is applied for up to 2 hours while supine and awake.
  • Experimental: Active CPAP (Overnight Study)
    CPAP at 8, 10, or 12 cm H2O is applied for up to 9 hours during the night.
  • Sham Comparator: Sham CPAP (Overnight Study)
    Sham CPAP is applied for up to 9 hours during the night.
  • Active Comparator: Sleeping in a head-up tilt position (Overnight Study)
    Sleeping with the bed tilted head-up by 10 degrees for up to 9 hours during the night.

Primary Outcome Measure

Systolic blood pressure (daytime) [ Time Frame: day 1 and 2 (within 2 hours of the intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Autonomic Dysfunction Center/ Vanderbilt University Medical CenterNashvilleTennessee37232
Bonnie K Black, RN, NP
[email protected]
615-343-6862
Luis E Okamoto, MD
[email protected]
(615) 936-6119
Andre Diedrich, MD, PhD (SUB_INVESTIGATOR)
Alfredo Gamboa, MD (SUB_INVESTIGATOR)
Cyndya A Shibao, MD (SUB_INVESTIGATOR)
Italo Biaggioni, MD (PRINCIPAL_INVESTIGATOR)
Luis E Okamoto, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Autonomic Dysfunction Center/ Vanderbilt University Medical Center· Nashville, TN

Related Studies