Condition or disease | Intervention/treatment |
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Postural Orthostatic Tachycardia Syndrome | Device: CRI device (non-invasive vitals sign measurement) |
Autonomic dysfunction (or dysautonomia) describes several medical conditions linked to the autonomic nervous system. One of these is Postural Orthostatic Tachycardia Syndrome (POTS). In pediatric populations, symptoms of autonomic dysfunction include an increase in heart rate when standing up (tachycardia), dizziness, nausea, vomiting, fatigue, headaches, abdominal discomfort, and sleep disturbances. POTS is specifically characterized by orthostatic intolerance and a forty beats per minute (bpm) increase in heart rate upon standing. The etiology of POTS is poorly understood, and there is limited literature on the management of POTS in pediatric populations. In the U.S., POTS is estimated to affect 1-3 million people.
The ability of the CRI algorithm to accurately distinguish individuals with varying tolerances to reduced central blood volume can be attributed to a unique function of the algorithm, which analyzes and compares the entirety of each waveform in a window of time to trend subtle features that correspond with varying degrees of central volume loss. CRI can also detect vascular changes associated with postural orthostatic tachycardia syndrome. CRI will be evaluated in subjects at supine and standing positions along with traditional orthostatic measures.
Following CRI measurements, subjects and their parents will be asked to complete a series of surveys to assess their psychosocial symptoms and functional impairment. The CRI measurement and survey completion will occur over the course of one clinic visit.
Study Type : | Observational |
Actual Enrollment : | 77 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Evaluation of the Compensatory Reserve Index and Psychosocial Factors in Pediatric Autonomic Dysfunction |
Actual Study Start Date : | June 1, 2019 |
Actual Primary Completion Date : | September 1, 2020 |
Actual Study Completion Date : | September 22, 2020 |
Group/Cohort | Intervention/treatment |
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Adolescents with POTS
Adolescents with Postural Orthostatic Tachycardia Syndrome (POTS) who meet diagnostic criteria for an orthostatic heart rate increase of >30, between ages 12-21 are eligible for this group. They will have a urine specific gravity conducted at the beginning of the clinic visit to assess hydration status. If urine specific gravity shows adequate hydration, subjects will proceed with orthostatic measurements with concomitant CRI measurements (via a non-invasive pulse oximetry monitor). (Subjects who are dehydrated will be given electrolyte drinks for rehydration and urine specific gravity will be rechecked after survey completion and before CRI and orthostatic measurements.) Following the CRI and orthostatic measurements, subjects and their parents will be asked to complete a series of surveys via REDcap. Interventions performed:
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Device: CRI device (non-invasive vitals sign measurement)
Survey administration, Orthostatic vital measurements
Other Name: Survey administration, Orthostatic vital measurements
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Adolescents without POTS, Control Group
Adolescents without Postural Orthostatic Tachycardia Syndrome (POTS) between ages 12-21 are eligible for this group. This group of subjects will have a urine specific gravity conducted at the beginning of the clinic visit to assess hydration status. If the urine specific gravity shows adequate hydration, subjects will proceed with orthostatic measurements with concomitant CRI measurements (via a non-invasive pulse oximetry monitor). (Subjects who are dehydrated will be given electrolyte drinks for rehydration and their urine specific gravity will be rechecked after survey completion and before CRI and orthostatic measurements.) Following the CRI and orthostatic measurements, subjects and their parents will be asked to complete a series of surveys via REDcap. Interventions performed:
|
Device: CRI device (non-invasive vitals sign measurement)
Survey administration, Orthostatic vital measurements
Other Name: Survey administration, Orthostatic vital measurements
|
Adolescents diagnosed with POTS who do not meet HR
Adolescents diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS) between ages 12-21, who do not meet diagnostic heart rate criteria, are eligible for this group. This group of subjects will have a urine specific gravity conducted at beginning of the clinic visit to assess hydration status. If the urine specific gravity shows adequate hydration, subjects will proceed with orthostatic measurements with concomitant CRI measurements (via a non-invasive pulse oximetry monitor). (Subjects who are dehydrated will be given electrolyte drinks for rehydration and urine specific gravity will be rechecked after survey completion and before CRI and orthostatic measurements.) Following the CRI and orthostatic measurements, subjects and their parents will be asked to complete a series of surveys via REDcap. Interventions performed:
|
Device: CRI device (non-invasive vitals sign measurement)
Survey administration, Orthostatic vital measurements
Other Name: Survey administration, Orthostatic vital measurements
|
Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
Children's Hospital Colorado | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Clio Pitula, PhD | Children's Hospital Colorado |
Tracking Information | |||||||
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First Submitted Date | May 24, 2019 | ||||||
First Posted Date | June 5, 2019 | ||||||
Last Update Posted Date | January 26, 2021 | ||||||
Actual Study Start Date | June 1, 2019 | ||||||
Actual Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | CRI in POTS in Adolescents | ||||||
Official Title | Evaluation of the Compensatory Reserve Index and Psychosocial Factors in Pediatric Autonomic Dysfunction | ||||||
Brief Summary | The investigators aim to study whether the Compensatory Reserve Index (CRI) (an FDA approved device that assesses intravascular volume) can be used to evaluate severity of Postural Orthostatic Tachycardia Syndrome (POTS) and whether the CRI value has a correlation with severity of psychosocial symptoms and functional impairment associated with POTS. | ||||||
Detailed Description |
Autonomic dysfunction (or dysautonomia) describes several medical conditions linked to the autonomic nervous system. One of these is Postural Orthostatic Tachycardia Syndrome (POTS). In pediatric populations, symptoms of autonomic dysfunction include an increase in heart rate when standing up (tachycardia), dizziness, nausea, vomiting, fatigue, headaches, abdominal discomfort, and sleep disturbances. POTS is specifically characterized by orthostatic intolerance and a forty beats per minute (bpm) increase in heart rate upon standing. The etiology of POTS is poorly understood, and there is limited literature on the management of POTS in pediatric populations. In the U.S., POTS is estimated to affect 1-3 million people. The ability of the CRI algorithm to accurately distinguish individuals with varying tolerances to reduced central blood volume can be attributed to a unique function of the algorithm, which analyzes and compares the entirety of each waveform in a window of time to trend subtle features that correspond with varying degrees of central volume loss. CRI can also detect vascular changes associated with postural orthostatic tachycardia syndrome. CRI will be evaluated in subjects at supine and standing positions along with traditional orthostatic measures. Following CRI measurements, subjects and their parents will be asked to complete a series of surveys to assess their psychosocial symptoms and functional impairment. The CRI measurement and survey completion will occur over the course of one clinic visit. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | The study population will include adolescents with POTS 12-21 years old and adolescents without POTS 12-21 years old. One parent will be required to attend the study visit. | ||||||
Condition | Postural Orthostatic Tachycardia Syndrome | ||||||
Intervention | Device: CRI device (non-invasive vitals sign measurement)
Survey administration, Orthostatic vital measurements
Other Name: Survey administration, Orthostatic vital measurements
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
77 | ||||||
Original Estimated Enrollment |
210 | ||||||
Actual Study Completion Date | September 22, 2020 | ||||||
Actual Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 12 Years to 21 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03974737 | ||||||
Other Study ID Numbers | 18-2618 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University of Colorado, Denver | ||||||
Study Sponsor | University of Colorado, Denver | ||||||
Collaborators | Colorado Clinical & Translational Sciences Institute | ||||||
Investigators |
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PRS Account | University of Colorado, Denver | ||||||
Verification Date | January 2021 |