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CRI in POTS in Adolescents (POTS)

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ClinicalTrials.gov Identifier: NCT03974737
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Colorado Clinical & Translational Sciences Institute
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment
Postural Orthostatic Tachycardia Syndrome Device: CRI device (non-invasive vitals sign measurement)

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
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Compensatory Reserve Index and Psychosocial Factors in Pediatric Autonomic Dysfunction
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Group/Cohort Intervention/treatment
Adolescents with POTS

Adolescents with 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:

  • Urine specific gravity measurement
  • CRI measurements, orthostatic vitals measurements
  • Survey administration
Device: CRI device (non-invasive vitals sign measurement)
Survey administration, Orthostatic vital measurements
Other Name: Survey administration, Orthostatic vital measurements

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:

  • Urine specific gravity measurement
  • CRI measurements, orthostatic vitals measurements
  • Survey administration
Device: CRI device (non-invasive vitals sign measurement)
Survey administration, Orthostatic vital measurements
Other Name: Survey administration, Orthostatic vital measurements




Primary Outcome Measures :
  1. Change in Compensatory Reserve Index (CRI) Values [ Time Frame: Minute 1 through minute 20 ]
    This is a value between 0 and 1. The CRI values will be noted from minute 1 to minute 20. This study has only one visit.

  2. Physical Symptoms Score as assessed by a Survey [ Time Frame: 1 day (study visit) ]
    Subjects will complete a survey to assess severity of physical symptoms (fatigue, dizziness, weakness, headache, chest pain, palpitations, sweating, shortness of breath, abdominal pain, nausea, vomiting, period pain, cries easily, altered temperature, discoloration of extremities, peripheral edema, numbness, brain fog, diarrhea, constipation, blurred vision, muscle pain, joint pain, exercise intolerance, insomnia, joint hypermobility, sensitivity to light, early society, etc.). Possible scores range from 0 to 10, with 10 indicating the most severe/debilitating symptoms and 0 indicating no physical symptoms/normal functionality. The survey will be completed during the study visit. This study has only one visit.

  3. Frequency of Anxiety in Days as assessed by a Survey [ Time Frame: 1 day (study visit) ]
    Subjects will complete a survey to assess how frequently (how many days) they experienced feelings of acute anxiety over the past month. The survey will be completed during the study visit. This study has only one visit.

  4. Hypermobility as evaluated by the Beighton scale [ Time Frame: 1 day (study visit) ]
    The Beighton Score is a validated measure used to evaluate hypermobility in children on a scale of 0-9 for different joints using 3 score bands. A higher Beighton score is associated with hypermobility. The assessment will be completed during the study visit. This study has only one visit.

  5. Frequency of Feelings of Stress in Days as assessed by a survey [ Time Frame: 1 day (study visit) ]
    Subjects will complete a survey to assess how frequently (how many days) they experienced feelings of stress over the past month. The survey will be completed during the study visit. This study has only one visit.

  6. Frequency of difficulty with sleep as assessed by a survey [ Time Frame: 1 day (study visit) ]
    Subjects will complete a survey to assess how long it takes them to fall asleep, how often they wake up, how long it takes to fall back asleep after waking up, and the frequency of difficulties with sleep.The survey will be completed during the study visit. This study has only one visit.

  7. Revised Child Anxiety and Depression Scale (RCADS and RCADS-P) [ Time Frame: 1 day (study visit) ]
    Subjects and their parent(s) will complete this well-established survey tool to assess the frequency of symptoms of anxiety and depression. The survey will be completed during the study visit. This study has only one visit.

  8. Functional disability inventory (FDI) [ Time Frame: 1 day (study visit) ]
    Participants and their parent(s) will be asked to complete a 15-question survey to evaluate the difficulty of daily tasks with a scale of impossible (4), a lot of trouble (3), some trouble (2), a little trouble (1), and no trouble (0) (39). This measure will be adapted very slightly to reflect the ubiquity of electronic media for today's adolescents, i.e., question 11 will be modified from "Watching TV" to "Watching TV and other screens." This measure yields an overall summed score. The survey will be completed during the study visit. This study has only one visit.

  9. Social Connectedness Scale [ Time Frame: 1 day (study visit) ]
    The Social Connectedness Scale, developed by Lee, assesses the responder's perceptions of social connectedness (i.e., the perception of interpersonal closeness with the social world) through 15 self-report items. The assessment will be completed during the study visit. This study has only one visit.

  10. Friendship scale [ Time Frame: 1 day (study visit) ]
    The "Close Friend Support/Regard" subscale of the Social Support Scale for Children and Adolescents will be used to assess the adolescent's perception that he/she has a close friend who he/she can tell problems to, who truly understands him/her, who he/she can complain to about things that bother them, who he/she can spend time with, and who really listens to what he/she says. This subscale comprises 6 items rated on a Likert scale from "really true for me" and "sort of true for me" for the positive phrasing of the item (e.g., "Some teenagers have a close friend who really understands them") to "sort of true for me" and "really true for me" for the negative phrasing of the item (e.g., "Other teenagers don't have a close friend who really understands them."). Given that some participants will be above 18 years, we will modify the wording to "some people". The assessment will be completed during the study visit. This study has only one visit.

  11. Frequency of friendship contact [ Time Frame: 1 day (study visit) ]
    Participants will be asked to indicate, over the past month, on how many occasions they have spent time with a close friend outside of school (i.e., free entry). The survey will be completed during the study visit. This study has only one visit.

  12. Family Assessment Device General Functioning scale (GFS) [ Time Frame: 1 day (study visit) ]
    The Family Assessment GFS is a twelve-point scale that evaluates the "overall health or pathology in family functioning" via analysis of six dimensions of family functioning: problem solving, communication, roles, affective responsiveness, affective involvement, and behavior control. This will be completed by subjects and their parent(s). The survey will be completed during the study visit. This study has only one visit.

  13. Sexual maturity Rating (Tanner stage) [ Time Frame: 1 day (study visit) ]
    This questionnaire with image demonstrations of the different Tanner stages will ask patients to self-report their appropriate Tanner stages.The questionnaire will be completed during the study visit. This study has only one visit.

  14. Parent Behavior Adult Responses to Children's Symptoms (ARCS) [ Time Frame: 1 day (study visit) ]
    The ARCS is a 29-point scale with a goal of assessment of parent responses to their children's symptoms (i.e. protectiveness, minimization, encouragement, and monitoring).The assessment will be completed during the study visit. This study has only one visit.

  15. Parent Mental Health- PHQ-9 [ Time Frame: 1 day (study visit) ]
    The Parent Mental Health scales, Parent Health Questionnaire 9 item scale (PHQ-9) and Generalized Anxiety Disorder 7 item scale (GAD-7), are short self-reported questionnaires that are widely used with established psychometrics in the parent population. The PHQ-9 assessment will be completed during the study visit. This study has only one visit.

  16. Parent Mental Health- GAD-7 [ Time Frame: 1 day (study visit) ]
    The Parent Mental Health scales, Parent Health Questionnaire 9 item scale (PHQ-9) and Generalized Anxiety Disorder 7 item scale (GAD-7), are short self-reported questionnaires that are widely used with established psychometrics in the parent population. The GAD-7 assessment will be completed during the study visit. This study has only one visit.



Information from the National Library of Medicine

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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
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.
Criteria

Inclusion Criteria:

  • Adolescent participants must be aged 12 to 21 years (inclusive).
  • Each participant must have at one parent/legal guardian who can provide informed consent for the adolescent and participate in the study by completing study questionnaires.
  • Moreover, as the majority of study measures are only validated for use in English, only English-speaking patients will be included in this study.

Exclusion Criteria:

  • Adolescents will be excluded from the study if they are outside the age range of 12-21 years old
  • Adolescents who are wards of the state
  • Adolescents who are incarcerated
  • Adolescents who are decisionally impaired (i.e., have difficulty understanding the protocol during the consent process, and/or research team member is unsure of individual's ability to correctly identify whether the research study would need to stop or not)
  • Adolescents who object at any time to participating in the study
  • Adolescents who have a pacemaker
  • Adolescents who are taking beta blocker medications
  • Adolescents who were were hospitalized in the past month for serious medical conditions affecting their cardiopulmonary system (note, this does not include recent hospitalizations for trauma or burns).
  • Adolescents will also be excluded if their parent/legal guardian(s) are unwilling to participate in the study and/or do not have legal custody of the adolescent participant.
  • Adolescents who do not speak English will be excluded from the study as majority of the study measures are only validated in English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974737


Contacts
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Contact: Niti Shahi, MD 720-777-0859 niti.shahi@childrenscolorado.org
Contact: Ryan Phillips, MD 720-777-5371 ryan.phillips@childrenscolorado.org

Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
Investigators
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Principal Investigator: Clio Pitula, PhD Children's Hospital Colorado

Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03974737     History of Changes
Other Study ID Numbers: 18-2618
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Colorado, Denver:
POTS
Postural Orthostatic Tachycardia Syndrome
Dysautonomia
CRI
Compensatory Reserve Index

Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases