Evaluation of Autonomic Function in Individuals With Cornelia de Lange Syndrome (CdLS)
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|ClinicalTrials.gov Identifier: NCT03113877|
Recruitment Status : Terminated (Difficulty in recruitment, Funding has run out.)
First Posted : April 14, 2017
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment|
|Cornelia de Lange Syndrome||Other: Autonomic Dysfunction Testing|
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Evaluation of Autonomic Function in Individuals With Cornelia de Lange Syndrome (CdLS), a Pilot Study.|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||September 1, 2017|
Clinical Testing for Autonomic Dysfunction
COMPASS-31 Survey completion. Autonomic Reflex Screen. Thermoregulatory Swear Test.
Other: Autonomic Dysfunction Testing
The participants with CdLS will complete the COMPASS-31 survey and will complete standard clinical testing for autonomic dysfunction including an autonomic reflex screen (tilt table and quantitative sudomotor axon reflex testing) and thermoregulatory sweat test (TST).
- Number of patients who tolerated 70 degree head up tilt table test [ Time Frame: 1 year ]Patients tolerating at least 5 minutes of tilt table
- Number of patients who show evidence of dysautonomia [ Time Frame: 1 year ]Dysautonomia measured by excessive heart rate (>40 bpm) on a tilt table test or reduced sweating on a thermoregulatory sweat test.
- Number of patients who tolerated thermoregulatory sweat test [ Time Frame: 1 year ]Patients tolerating at least 15 minutes of thermoregulatory sweat test
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): NCT03113877
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amie E Jones, MD||Mayo Clinic|