Hypotension, OrthostaticNCT02280369
Posture Detection for Automated Abdominal Binder
An observational study of Hypotension, Orthostatic, run by Vanderbilt University at 1 site in United States.
Trial summary
The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in autonomic failure patients. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Orthostatic
- What is being tested?
- Automated abdominal binder
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2017
- Phase
- Observational
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Body mass index <30 Kg/m2.
- Able and willing to provide informed consent.
Who cannot join
- Pregnancy.
- Any major medical problems or systemic illnesses known to produce orthostatic intolerance.
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing during the screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in autonomic failure patients. The purpose of this study is to evaluate the performance of the binder in detecting body posture during different types of human motion patterns and activities of daily living, and to develop new (and better) ways to detect upright posture. In particular, the investigators want to determine if activities of daily living, normally encountered by patients (lying down, sitting, standing, walking, and climbing up and down steps), interfere with the detection of upright posture used to trigger the device. Studies will be conducted in healthy subjects because the main purpose of this study is to evaluate posture detection rather than treating orthostatic hypotension.
Read the detailed description
The Primary Objective of this study is to develop and validate the algorithm needed to detect upright posture with a waist 3-axis accelerometer. A Secondary Objective is to determine the performance reliability of posture detection of the thigh and waist accelerometers when exposed to activities of daily living (standing, walking, climbing stairs). We will test the primary and secondary objectives in normal subjects using a single study design. Studies for both objectives will be conducted simultaneously on each subject on a single study day. Normal subjects will wear a device with the waist accelerometer incorporated within the controller box.
Subjects will be instrumented with the abdominal belt and controller box containing the waist accelerometer sensor. The external accelerometer sensor will be fixed with a Velcro around the thigh. In addition, subjects will wear two commercially available accelerometer sensors: 1) the ActivPal on the thigh of the other leg, and 2) an external accelerometer attached to the back of the belt at the level of the waist. The ActivPal can detect the upright posture but cannot distinguish between supine and sitting. The sensor placed on the back will be less affected by belly size in case of obese subjects. Both sensors will be used as a reference and for comparison. We will record all accelerometer signals during different body positions and activities. The activities will include lying down, sitting, getting up and standing still, walking, and climbing up and down steps for about one minute each for a total of 15-20 minutes per group of activities. Participants will perform 3 groups of activities. The order of activities within each group will be randomized. We might also ask you to perform ~3 small jumps to synchronize the sensors at the beginning, middle and the end of each set of activities.
- Conditions
- Hypotension, Orthostatic
- Being tested
- Automated abdominal binder
- Keywords
- posture detection, healthy subjects
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated abdominal binderDevice
Inflatable abdominal binder
| Study group | Role | What they receive |
|---|---|---|
| automated abdominal binder | automated abdominal binder with waist and thigh accelerometers, and ActivPAL Receives: Device: Automated abdominal binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of times the thigh and waist accelerometer sensors correctly detect upright posture.
Measured: during 5-10 minutes performing each activity (lying down, sitting, standing, climbing steps, walking)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension, OrthostaticStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Italo Biaggioni, Vanderbilt University
- Investigators
- Italo Biaggioni, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280369
- Sponsor's protocol ID
- 140749
- Status last verified
- Jan 2017
- First submitted
- 22 Sep 2014
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture Detection for Automated Abdominal Binder
- ClinicalTrials.gov ID
- NCT02280369
- Acronym / sponsor ID
- 140749
- Conditions
- Hypotension, Orthostatic
- Keywords
- posture detection, healthy subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Oct 2014 (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 automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in autonomic failure patients. The purpose of this study is to evaluate the performance of the binder in detecting body posture during different types of human motion patterns and activities of daily living, and to develop new (and better) ways to detect upright posture. In particular, the investigators want to determine if activities of daily living, normally encountered by patients (lying down, sitting, standing, walking, and climbing up and down steps), interfere with the detection of upright posture used to trigger the device. Studies will be conducted in healthy subjects because the main purpose of this study is to evaluate posture detection rather than treating orthostatic hypotension.
Detailed description
The Primary Objective of this study is to develop and validate the algorithm needed to detect upright posture with a waist 3-axis accelerometer. A Secondary Objective is to determine the performance reliability of posture detection of the thigh and waist accelerometers when exposed to activities of daily living (standing, walking, climbing stairs). We will test the primary and secondary objectives in normal subjects using a single study design. Studies for both objectives will be conducted simultaneously on each subject on a single study day. Normal subjects will wear a device with the waist accelerometer incorporated within the controller box.
Subjects will be instrumented with the abdominal belt and controller box containing the waist accelerometer sensor. The external accelerometer sensor will be fixed with a Velcro around the thigh. In addition, subjects will wear two commercially available accelerometer sensors: 1) the ActivPal on the thigh of the other leg, and 2) an external accelerometer attached to the back of the belt at the level of the waist. The ActivPal can detect the upright posture but cannot distinguish between supine and sitting. The sensor placed on the back will be less affected by belly size in case of obese subjects. Both sensors will be used as a reference and for comparison. We will record all accelerometer signals during different body positions and activities. The activities will include lying down, sitting, getting up and standing still, walking, and climbing up and down steps for about one minute each for a total of 15-20 minutes per group of activities. Participants will perform 3 groups of activities. The order of activities within each group will be randomized. We might also ask you to perform ~3 small jumps to synchronize the sensors at the beginning, middle and the end of each set of activities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| automated abdominal binder | – | Device: Automated abdominal binderautomated abdominal binder with waist and thigh accelerometers, and ActivPAL |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Body mass index <30 Kg/m2.
- Able and willing to provide informed consent.
Key exclusion criteria (3 listed)
- Pregnancy.
- Any major medical problems or systemic illnesses known to produce orthostatic intolerance.
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing during the screening
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 |
|---|---|---|
| Automated abdominal binderInflatable abdominal binder | Device | automated abdominal binder |
Primary outcome
Percentage of times the thigh and waist accelerometer sensors correctly detect upright posture.
Time frame: during 5-10 minutes performing each activity (lying down, sitting, standing, climbing steps, walking)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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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.
Italo Biaggioni, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, Orthostatic, run by Vanderbilt University 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jan 2017. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of times the thigh and waist accelerometer sensors correctly detect upright posture. (time frame: during 5-10 minutes performing each activity (lying down, sitting, standing, climbing steps, walking)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2017.