Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00962884
Other study ID # 090600
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 2010
Est. completion date December 2022

Study information

Verified date November 2021
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Orthostatic hypotension is commonly described, especially in an elderly population. Using data from a national hospital inpatient database, Shibao et al. have reported that the annual hospitalization rate for orthostatic hypotension was 233 per 100000 among patients older than 75 years. Orthostatic hypotension is associated with an increased risk of falls, increased risk of coronary heart disease and mortality. Orthostatic hypotension is defined as a fall in systolic blood pressure of at least 20 mmHg within 3 minutes upon standing 3. Patients with orthostatic hypotension commonly experience lightheadedness or syncope. In normal individuals, changes in posture do not results in significant changes in blood pressure due to physiological compensation for the gravity-mediated pooling of blood in the lower limbs with upright posture. Unfortunately, in patients with impairments of the autonomic nervous system, one or more of these adaptive mechanisms fail, and an orthostatic fall in blood pressure results. In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce orthostatic hypotension in patients with neurogenic orthostatic hypotension.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Device:
Inspiratory Threshold Device (Res-Q-Gard ITD)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Sham Inspiratory Threshold Device
Breathing through device similar to active device but with the one-way threshold valve removed.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Alfredo Gamboa Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub 2005 Apr 28. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Magnitude of drop in Systolic Blood Pressure during head-up tilt 1 min
Secondary "Standing Time" tolerated with systolic blood pressure above 70 mmHg 10 min (max)
Secondary Symptom rating 10 min (max)
Secondary Hemodynamics (non-invasive) 10 min
See also
  Status Clinical Trial Phase
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Recruiting NCT05941819 - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT02897063 - Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Phase 1
Completed NCT02726776 - Suspension Syndrome N/A
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Not yet recruiting NCT04440085 - RaGuS Trial by Postoperative Patients Phase 4
Recruiting NCT03732716 - Sarcopenia and Orthostatic Hypotension
Recruiting NCT05621460 - The Effect of Water Carbonation on Orthostatic Tolerance N/A
Completed NCT02632318 - Dawn Simulation and Postural Hypotension Phase 4
Completed NCT05729724 - Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)
Completed NCT03721393 - Data Collection - Of Syncope Tilt Table Testing Study
Completed NCT01030874 - Orthostatic Hypotension Treatment on Rehab Unit N/A
Completed NCT01223391 - Abdominal Compression in Orthostatic Hypotension N/A
Completed NCT01362751 - Orthostatic Hypotension in Elderly Nursing Home Residents N/A
Completed NCT00248807 - A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury. N/A
Terminated NCT00137319 - Impedance Threshold Device Tilt Study N/A
Completed NCT05233865 - Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension N/A
Suspended NCT01370512 - Droxidopa / Pyridostigmine in Orthostatic Hypotension Phase 2
Recruiting NCT00452712 - Orthostatic Hypotension in Children With Acute Febrile Illness Phase 2