X-Linked Hypohidrotic Ectodermal DysplasiaNCT01135888
Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia
An observational study of X-Linked Hypohidrotic Ectodermal Dysplasia and Exercise-induced Rise of Body Temperature, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- X-Linked Hypohidrotic Ectodermal Dysplasia, Exercise-induced Rise of Body Temperature
- What is being tested?
- Skin cooling devices
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Feb 2010
- 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 7 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: subjects with X-chromosomally inherited hypohidrotic ectodermal dysplasia (HED) and age-matched controls
Who may be able to join
- for patients: hypohidrotic ectodermal dysplasia caused by EDA gene mutations
- regular fluid intake prior to the investigation
- written informed consent
Who cannot join
- acute febrile illness
- acute or chronic heart disease
- arterial hypertension
- gastrointestinal disorders
- implantable electronic devices
- MRI investigation scheduled for the 5 days subsequent to the study
- clinical signs or diagnostic findings of dehydration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia (Christ-Siemens-Touraine Syndrome)
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.
- Being tested
- Skin cooling devices
- Keywords
- hypohidrotic ectodermal dysplasia, exertional hyperthermia, cooling device
- Medical subject headings
- Ectodermal Dysplasia 1, Anhidrotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin cooling devicesDevice
Also called Cooline
Cooling vest and cooling bandana
| Study group | Role | What they receive |
|---|---|---|
| HED children | Not described | |
| HED adolescents | Not described Receives: Device: Skin cooling devices | |
| Control children | Not described | |
| Control adolescents | Not described Receives: Device: Skin cooling devices |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for X-Linked Hypohidrotic Ectodermal DysplasiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Collaborators
- Pervormance GmbH
- Responsible party
- Principal investigator, Prof. Dr. Holm Schneider, University Hospital Erlangen
- Investigators
- Holm Schneider, MD, Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135888
- Sponsor's protocol ID
- ED09
- Status last verified
- Aug 2021
- First submitted
- 2 Jun 2010
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hammersen JE, Neukam V, Nusken KD, Schneider H. Systematic evaluation of exertional hyperthermia in children and adolescents with hypohidrotic ectodermal dysplasia: an observational study. Pediatr Res. 2011 Sep;70(3):297-301. doi: 10.1203/PDR.0b013e318227503b.
PubMed 21646941
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia (Christ-Siemens-Touraine Syndrome)
- ClinicalTrials.gov ID
- NCT01135888
- Acronym / sponsor ID
- ED09
- Keywords
- hypohidrotic ectodermal dysplasia, exertional hyperthermia, cooling device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Collaborators
- Pervormance GmbH
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 Jun 2010 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HED children | – | – |
| HED adolescents | – | Device: Skin cooling devices |
| Control children | – | – |
| Control adolescents | – | Device: Skin cooling devices |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- subjects with X-chromosomally inherited hypohidrotic ectodermal dysplasia (HED) and age-matched controls
Key inclusion criteria (3 listed)
- for patients: hypohidrotic ectodermal dysplasia caused by EDA gene mutations
- regular fluid intake prior to the investigation
- written informed consent
Key exclusion criteria (7 listed)
- acute febrile illness
- acute or chronic heart disease
- arterial hypertension
- gastrointestinal disorders
- implantable electronic devices
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 |
|---|---|---|
| Skin cooling devicesAlso: CoolineCooling vest and cooling bandana | Device | Control adolescents, HED adolescents |
Primary outcome
Not reported in the source record.
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 19 Aug 2021.
- Derived from this study: PubMed 21646941Hammersen JE, Neukam V, Nusken KD, Schneider H. Systematic evaluation of exertional hyperthermia in children and adolescents with hypohidrotic ectodermal dysplasia: an observational study. Pediatr Res. 2011 Sep;70(3):297-301. doi: 10.1203/PDR.0b013e318227503b.
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X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)
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.
Holm Schneider, MD principal investigator
University Hospital Erlangen
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 X-Linked Hypohidrotic Ectodermal Dysplasia and Exercise-induced Rise of Body Temperature, run by University Hospital Erlangen at 1 site in Germany.
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 3 inclusion and 7 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 19 Aug 2021. 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 Germany. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135888, which also lists 1 linked publication.
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 19 Aug 2021.