Orthostatic HypotensionNCT00962884
Breathing Device for Orthostatic Hypotension (OH)
A study testing Inspiratory Threshold Device (Res-Q-Gard ITD) in people with Orthostatic Hypotension, run by Alfredo Gamboa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Inspiratory Threshold Device (Res-Q-Gard ITD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2195
About this study
Official title: Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension
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.
Read the detailed 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.
- Conditions
- Orthostatic Hypotension
- Being tested
- Inspiratory Threshold Device (Res-Q-Gard ITD), Sham Inspiratory Threshold Device
- Keywords
- Orthostatic hypotension, Breathing, Blood pressure, standing
- Medical subject headings
- Hypotension, Orthostatic, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Threshold Device (Res-Q-Gard ITD)Device
Also called Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Sham Inspiratory Threshold DeviceDevice
Also called Res-Q-Gard device 7.0 (with active valve removed)
Breathing through device similar to active device but with the one-way threshold valve removed.
| Study group | Role | What they receive |
|---|---|---|
| ITD breathing device | Experimental | Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc. Receives: 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. Receives: Device: Sham Inspiratory Threshold Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of drop in Systolic Blood Pressure during head-up tilt
Measured: 1 min
Secondary outcomes (3)
"Standing Time" tolerated with systolic blood pressure above 70 mmHg
Measured: 10 min (max)
Symptom rating
Measured: 10 min (max)
Hemodynamics (non-invasive)
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startDec 2010
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: No volunteers were enrolled, study was closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfredo Gamboa
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor-investigator, Alfredo Gamboa, Vanderbilt University Medical Center
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, Vanderbilt University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962884
- Sponsor's protocol ID
- 090600
- Status last verified
- Nov 2021
- First submitted
- 18 Aug 2009
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17334239Convertino 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.
PubMed 15864634Shibao 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.
PubMed 17976425
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT00962884
- Acronym / sponsor ID
- 090600
- Conditions
- Orthostatic Hypotension
- Keywords
- Orthostatic hypotension, Breathing, Blood pressure, standing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No volunteers were enrolled, study was closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alfredo GamboaUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- Dec 2010
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITD breathing device | Experimental | Device: Inspiratory Threshold Device (Res-Q-Gard ITD)Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc. |
| Sham Device | Sham comparator | Device: Sham Inspiratory Threshold DeviceBreathing device similar to active Res-Q-Gard device but with one-way resistance valve removed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Threshold Device (Res-Q-Gard ITD)Also: Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance. | Device | ITD breathing device |
| Sham Inspiratory Threshold DeviceAlso: Res-Q-Gard device 7.0 (with active valve removed)Breathing through device similar to active device but with the one-way threshold valve removed. | Device | Sham Device |
Primary outcome
Magnitude of drop in Systolic Blood Pressure during head-up tilt
Time frame: 1 min
3 secondary outcomes
"Standing Time" tolerated with systolic blood pressure above 70 mmHg
Time frame: 10 min (max)
Symptom rating
Time frame: 10 min (max)
Hemodynamics (non-invasive)
Time frame: 10 min
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Background: PubMed 17334239Convertino 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.
- Background: PubMed 15864634Convertino 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.
- Background: PubMed 17976425Shibao 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.
- Vanderbilt Autonomic Dysfunction Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish R Raj, MD MSCI principal investigator
Vanderbilt University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Threshold Device (Res-Q-Gard ITD) in people with Orthostatic Hypotension, run by Alfredo Gamboa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of drop in Systolic Blood Pressure during head-up tilt (time frame: 1 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00962884, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.