NCT00962884

Brief Summary

The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease blood pressure drops on standing in patients with orthostatic hypotension.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

12 years

First QC Date

August 18, 2009

Last Update Submit

November 13, 2021

Conditions

Orthostatic Hypotension

Keywords

Orthostatic hypotensionBreathingBlood pressurestanding

Outcome Measures

Primary Outcomes (1)

  • Magnitude of drop in Systolic Blood Pressure during head-up tilt

    1 min

Secondary Outcomes (3)

  • "Standing Time" tolerated with systolic blood pressure above 70 mmHg

    10 min (max)

  • Symptom rating

    10 min (max)

  • Hemodynamics (non-invasive)

    10 min

Study Arms (2)

ITD breathing device

EXPERIMENTAL

Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.

Device: Inspiratory Threshold Device (Res-Q-Gard ITD)

Sham Device

SHAM COMPARATOR

Breathing device similar to active Res-Q-Gard device but with one-way resistance valve removed.

Device: Sham Inspiratory Threshold Device

Interventions

Inspiratory Threshold Device (Res-Q-Gard ITD)DEVICE

Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.

Also known as: Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)
ITD breathing device
Sham Inspiratory Threshold DeviceDEVICE

Breathing through device similar to active device but with the one-way threshold valve removed.

Also known as: Res-Q-Gard device 7.0 (with active valve removed)
Sham Device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with neurogenic orthostatic hypotension by the Vanderbilt Autonomic Dysfunction Center
  • Decrease in systolic blood pressure ≥ 20 mmHg with position change from supine to standing (10 minutes)
  • Evidence of reproducibility suggestive of non-reversible nervous system origin for the orthostatic hypotension
  • Age between 18-80 years
  • Male and female subjects are eligible
  • Able and willing to provide informed consent

You may not qualify if:

  • Overt cause for orthostatic hypotension (such as acute dehydration)
  • Inability to give, or withdrawal of, informed consent
  • Pregnant
  • Other factors which in the investigator's opinion would prevent the subject from completing the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2195, United States

Location

Related Publications (3)

  • Convertino VA, Ryan KL, Rickards CA, Cooke WH, Idris AH, Metzger A, Holcomb JB, Adams BD, Lurie KG. Inspiratory resistance maintains arterial pressure during central hypovolemia: implications for treatment of patients with severe hemorrhage. Crit Care Med. 2007 Apr;35(4):1145-52. doi: 10.1097/01.CCM.0000259464.83188.2C.

    PMID: 17334239BACKGROUND

  • Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.

    PMID: 15864634BACKGROUND

  • Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009.

    PMID: 17976425BACKGROUND

Related Links

MeSH Terms

Conditions

Hypotension, OrthostaticRespiratory Aspiration

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Satish R Raj, MD MSCI

    Vanderbilt University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant Professor of Medicine

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 20, 2009

Study Start

December 1, 2010

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

US(1)