An observational study in X-Linked Hypohidrotic Ectodermal Dysplasia and Exercise-induced Rise of Body Temperature, sponsored by University Hospital Erlangen. Completed at 1 site in Germany. Open to male participants aged 7 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by University Hospital Erlangen · Observational
Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm environment. In this study, the effects of physical exercise are investigated in boys and male adolescents with X-chromosomally inherited HED as well as age-matched controls, who undergo standardized exertion on a bicycle ergometer at ambient temperatures of 25°C and 30°C. Body core temperature during and after ergometry, heart rate, performance, and serum lactate as a marker of metabolic stress are measured. Subjects with HED are expected to show an endangering rise of body temperature in connection with physical exercise. To clarify, whether novel cooling devices may reduce the likelihood of overheating, the effects of such devices are evaluated at 30°C.
21 studies on the registry are indexed under Ectodermal Dysplasia 1, Anhidrotic; 1 is open to participants now.
This study's enrollment of 28 is below the median of 33 across 16 observational studies indexed under Ectodermal Dysplasia 1, Anhidrotic.
Browse Ectodermal Dysplasia 1, Anhidrotic studies →University Hospital Erlangen is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
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subjects with X-chromosomally inherited hypohidrotic ectodermal dysplasia (HED) and age-matched controls
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Skin cooling devices
Device: Skin cooling devices
Cooling vest and cooling bandana
Also known as: Cooline
The record gives a start of Apr 2009, a primary completion of Feb 2010 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Ectodermal Dysplasia 1, Anhidrotic →
University Hospital Erlangen