ROSAH SyndromeNCT07814209
A Method Characterization Study to Evaluate Thermoregulatory Sweat Production in Healthy Volunteers and Patients With ROSAH Syndrome)
A study of ROSAH Syndrome and Anhidrosis, run by The Third Xiangya Hospital of Central South University.
Trial summary
This study is designed to characterize a new quantitative method for measuring sweat production induced by controlled heat exposure. Approximately 20 healthy volunteers and up to 10 patients with ROSAH syndrome will be enrolled. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ROSAH Syndrome, Anhidrosis, Hypohidrosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female participants 12 to 65 years of age at screening.
- Adolescent participants must be Tanner stage IV or V or have reached an equivalent level of sexual maturity.
- For the healthy-volunteer cohort, the participant must be considered healthy based on medical history and investigator assessment.
- For the ROSAH syndrome cohort, the participant must have a genetically and clinically confirmed diagnosis of ROSAH syndrome and must be considered clinically stable by the investigator.
- Able and willing to complete three controlled sauna heat-exposure tests.
- Able to remain seated in a temperature-controlled sauna chamber for up to 30 minutes.
Show all 12Show fewer
- Willing to wear only underwear during testing; female participants may wear a bra.
- Willing to have hair at testing sites trimmed or shaved if necessary.
- Able to drink 300 mL of water before each test.
- Able and willing to comply with study requirements, instructions, and protocol restrictions and likely to complete the study as planned.
- Able to provide written informed consent.
- For minors, written informed consent must be provided by a parent or legal representative, and written assent must be provided by the participant.
Who cannot join
- Baseline body temperature greater than 37.5°C on the day of testing.
- Fever, acute infection, or acute illness within 7 days before testing.
- History of heat stroke, severe heat intolerance, heat-associated syncope, or severe dehydration.
- Clinically significant cardiovascular disease, uncontrolled hypertension, cardiac arrhythmia, or unstable respiratory disease.
- Severe anemia or unstable cytopenia, in the investigator's judgment.
- Active skin disease, wound, dermatitis, or skin infection at a filter paper placement site.
Show all 12Show fewer
- Pregnant or breastfeeding.
- Current use of medication that may substantially affect sweating or thermoregulation unless approved by the investigator, including anticholinergic agents, systemic beta blockers, diuretics, selected antihistamines, or medications that reduce heat tolerance.
- Use of depilatory cream, waxing, an epilator, or another chemical or mechanical hair-removal method other than shaving from 7 days before the first sweat test through the final sweat test.
- Laser, intense pulsed light, or other energy-based hair removal within 3 months before screening.
- Unable to comply with clothing, privacy, or testing requirements.
- Any other condition that, in the investigator's judgment, would create an unacceptable risk or interfere with interpretation of the study results.
About this study
Official title: A Method Characterization Study to Evaluate Thermoregulatory Sweat Production in Healthy Volunteers and Patients With ROSAH Syndrome
This study is designed to characterize a new quantitative method for measuring sweat production induced by controlled heat exposure. Approximately 20 healthy volunteers and up to 10 patients with ROSAH syndrome will be enrolled. Sweat production will be quantified using a gravimetric filter-paper technique during standardized 30-minute heat exposure in a temperature-controlled sauna chamber. Each participant will complete three repeated testing sessions. The study will also pilot a questionnaire to evaluate the self-reported impact and severity of hypohidrosis/anhidrosis.
Read the detailed description
This multicenter, controlled-environment, repeated-measures study is designed as a physiological challenge test. The study will be initiated in healthy volunteers to characterize the feasibility, reproducibility, and reference distribution of the sweat measurement method under controlled heat exposure. Upon confirmation of the method's suitability, the study will proceed to enroll participants with ROSAH syndrome. Each participant will complete three heat-exposure sessions in a sauna, separated by 1-3 days, with all sessions completed within a maximum of one week. The primary outcome is Total Gravimetric Sweat Production (TGSP). Safety evaluations will include monitoring of adverse events, vital signs, and body temperature.
- Conditions
- ROSAH Syndrome, Anhidrosis, Hypohidrosis
- Being tested
- Standardized Controlled Heat Exposure With Gravimetric Sweat Collection
- Keywords
- Sweat Test, Thermoregulation, Weighted Filter Paper, ROSAH Syndrome, ALPK1 Gene, Healthy Volunteers
- Medical subject headings
- Hypohidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Controlled Heat Exposure With Gravimetric Sweat CollectionProcedure or surgery
Participants will drink 300 mL of water before testing and will sit in a temperature-controlled sauna chamber for approximately 30 minutes. The mean internal exposure temperature will be maintained above 42°C and below 44°C, with an adjustable nominal operating set point of approximately 45°C. Preweighed filter papers will be attached to prespecified anatomical sites and will be removed and reweighed immediately after exposure using a calibrated analytical balance. Body temperature, heart rate, symptoms, sauna temperature, and relative humidity will be monitored. The procedure will be stopped early if prespecified safety or intolerance criteria are met. The procedure will be repeated three times, with sessions at least 1 day apart and completed within 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Heat Exposure and Gravimetric Sweat Assessment | Experimental | Approximately 20 healthy volunteers and up to 10 participants with genetically confirmed ROSAH syndrome will undergo three standardized passive heat-exposure sessions in a temperature-controlled sauna chamber. Each session will last approximately 30 minutes, will be separated by at least 1 day, and all three sessions will be completed within 7 days. Preweighed filter papers will be placed at the chest, back, axilla, forehead, and forearm and reweighed after exposure to quantify total and regional sweat production. Physiologic and environmental parameters will be monitored throughout the procedure. Receives: Procedure: Standardized Controlled Heat Exposure With Gravimetric Sweat Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Gravimetric Sweat Production (TGSP)
TGSP is defined as the sum of sweat mass collected from all prespecified and evaluable anatomical sites during a standardized heat-exposure session. For each site, sweat mass is calculated as the post-exposure filter paper weight minus the pre-exposure filter paper weight. TGSP will be reported in milligrams and may also be standardized by filter paper area according to the statistical analysis plan.
Measured: During each of three approximately 30-minute heat-exposure sessions, with sessions at least 1 day apart and all three sessions completed within 7 days.
Secondary outcomes (13)
Regional Gravimetric Sweat Production by Anatomical Site
Sweat mass at the chest, back, axilla, forehead, and forearm will be calculated separately as the post-exposure filter paper weight minus the pre-exposure filter paper weight. Results will be reported in milligrams and may also be standardized by filter paper area.
Measured: During each of three approximately 30-minute heat-exposure sessions, with sessions at least 1 day apart and completed within 7 days.
Test-Retest Reliability of Total Gravimetric Sweat Production
Short-term test-retest reliability of TGSP across the three heat-exposure sessions will be assessed using the intraclass correlation coefficient and graphical repeated-measures assessments.
Measured: Across the three heat-exposure sessions completed within 7 days.
Within-Participant Variability of Total Gravimetric Sweat Production
Within-participant variability in TGSP across the three sessions will be summarized using within-participant standard deviation and coefficient of variation.
Measured: Across the three heat-exposure sessions completed within 7 days.
Test-Retest Reliability and Variability of Regional Sweat Production
Test-Retest Reliability and Variability of Regional Sweat Production
Measured: Across the three heat-exposure sessions completed within 7 days.
Total and Regional Sweat Production by Clinical Group, Sex, and Age Category
TGSP and regional sweat production will be summarized descriptively by clinical group (healthy volunteers and participants with ROSAH syndrome), sex, and age category (adolescents and adults). Comparisons are exploratory and are not powered for confirmatory hypothesis testing.
Measured: During the three heat-exposure sessions completed within 7 days.
Sauna Chamber Temperature Stability
Sauna chamber temperature will be recorded continuously or at protocol-defined frequent intervals. Stability will be summarized using descriptive statistics and the extent of time within the protocol-defined operating range.
Measured: Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.
Sauna Chamber Relative Humidity Stability
Sauna chamber relative humidity will be recorded continuously or at protocol-defined frequent intervals and summarized descriptively to characterize environmental consistency across sessions.
Measured: Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.
Change in Body Temperature During Controlled Heat Exposure
Body temperature will be measured before sauna entry, at least every 5 minutes during exposure if not continuously monitored, at the end of exposure, and during recovery when clinically indicated. Change from the pre-exposure value and maximum observed temperature will be summarized.
Measured: Before, during, immediately after, and during recovery from each of the three heat-exposure sessions completed within 7 days.
Heat-Exposure Sessions Terminated Early Due to Body Temperature of 38.0°C or Higher or Participant Intolerance
The number and percentage of planned heat-exposure sessions that are terminated early because body temperature reaches or exceeds 38.0°C, the participant requests discontinuation, or the investigator identifies clinically significant intolerance will be summarized.
Measured: During the three heat-exposure sessions completed within 7 days.
Incidence, Type, and Severity of Adverse Events and Heat-Related Intolerance Events
Adverse events and procedure-related intolerance events will be collected and summarized by event type, severity, seriousness, and relationship to study procedures. Events of interest include heat intolerance, dizziness, presyncope or syncope, headache, nausea or vomiting, fatigue, palpitations, skin irritation, and clinically significant body-temperature elevation.
Measured: From initiation of the first study procedure through the follow-up assessment, up to approximately 17 days per participant.
Anhidrosis/Hypohidrosis Impact Questionnaire Total Score
The questionnaire contains six scored items covering heat intolerance, frequency of overheating, activity limitation, use of cooling measures, perceived ability to sweat, and overheating-related symptoms. Each item is scored from 0 to 4; the total score ranges from 0 to 24, with higher scores indicating greater heat intolerance or impact of impaired sweating.
Measured: Before the first heat-exposure session and 8 to 10 days after the final heat-exposure session.
Change in Anhidrosis/Hypohidrosis Impact Questionnaire Total Score
Change in questionnaire total score will be calculated as the follow-up total score minus the baseline total score. Item-level changes may also be summarized descriptively.
Measured: From before the first heat-exposure session to 8 to 10 days after the final heat-exposure session.
Test-Retest Reliability of the Anhidrosis/Hypohidrosis Impact Questionnaire
Short-term stability and test-retest reliability of questionnaire total scores will be evaluated using paired descriptive summaries, correlations, intraclass correlation coefficients, and graphical assessments, as appropriate.
Measured: Between the baseline assessment before the first heat-exposure session and the follow-up assessment 8 to 10 days after the final heat-exposure session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ROSAH SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Farm Inc
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814209
- Sponsor's protocol ID
- DF-GSP-1001
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Method Characterization Study to Evaluate Thermoregulatory Sweat Production in Healthy Volunteers and Patients With ROSAH Syndrome
- ClinicalTrials.gov ID
- NCT07814209
- Acronym / sponsor ID
- DF-GSP-1001
- Conditions
- ROSAH Syndrome, Anhidrosis, Hypohidrosis
- Keywords
- Sweat Test, Thermoregulation, Weighted Filter Paper, ROSAH Syndrome, ALPK1 Gene, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Drug Farm Inc
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- 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.
This study is designed to characterize a new quantitative method for measuring sweat production induced by controlled heat exposure. Approximately 20 healthy volunteers and up to 10 patients with ROSAH syndrome will be enrolled. Sweat production will be quantified using a gravimetric filter-paper technique during standardized 30-minute heat exposure in a temperature-controlled sauna chamber. Each participant will complete three repeated testing sessions. The study will also pilot a questionnaire to evaluate the self-reported impact and severity of hypohidrosis/anhidrosis.
Detailed description
This multicenter, controlled-environment, repeated-measures study is designed as a physiological challenge test. The study will be initiated in healthy volunteers to characterize the feasibility, reproducibility, and reference distribution of the sweat measurement method under controlled heat exposure. Upon confirmation of the method's suitability, the study will proceed to enroll participants with ROSAH syndrome. Each participant will complete three heat-exposure sessions in a sauna, separated by 1-3 days, with all sessions completed within a maximum of one week. The primary outcome is Total Gravimetric Sweat Production (TGSP). Safety evaluations will include monitoring of adverse events, vital signs, and body temperature.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controlled Heat Exposure and Gravimetric Sweat Assessment | Experimental | Procedure: Standardized Controlled Heat Exposure With Gravimetric Sweat CollectionApproximately 20 healthy volunteers and up to 10 participants with genetically confirmed ROSAH syndrome will undergo three standardized passive heat-exposure sessions in a temperature-controlled sauna chamber. Each session will last approximately 30 minutes, will be separated by at least 1 day, and all three sessions will be completed within 7 days. Preweighed filter papers will be placed at the chest, back, axilla, forehead, and forearm and reweighed after exposure to quantify total and regional sweat production. Physiologic and environmental parameters will be monitored throughout the procedure. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Male or female participants 12 to 65 years of age at screening.
- Adolescent participants must be Tanner stage IV or V or have reached an equivalent level of sexual maturity.
- For the healthy-volunteer cohort, the participant must be considered healthy based on medical history and investigator assessment.
- For the ROSAH syndrome cohort, the participant must have a genetically and clinically confirmed diagnosis of ROSAH syndrome and must be considered clinically stable by the investigator.
- Able and willing to complete three controlled sauna heat-exposure tests.
Key exclusion criteria (12 listed)
- Baseline body temperature greater than 37.5°C on the day of testing.
- Fever, acute infection, or acute illness within 7 days before testing.
- History of heat stroke, severe heat intolerance, heat-associated syncope, or severe dehydration.
- Clinically significant cardiovascular disease, uncontrolled hypertension, cardiac arrhythmia, or unstable respiratory disease.
- Severe anemia or unstable cytopenia, in the investigator's judgment.
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 |
|---|---|---|
| Standardized Controlled Heat Exposure With Gravimetric Sweat CollectionParticipants will drink 300 mL of water before testing and will sit in a temperature-controlled sauna chamber for approximately 30 minutes. The mean internal exposure temperature will be maintained above 42°C and below 44°C, with an adjustable nominal operating set point of approximately 45°C. Preweighed filter papers will be attached to prespecified anatomical sites and will be removed and reweighed immediately after exposure using a calibrated analytical balance. Body temperature, heart rate, symptoms, sauna temperature, and relative humidity will be monitored. The procedure will be stopped early if prespecified safety or intolerance criteria are met. The procedure will be repeated three times, with sessions at least 1 day apart and completed within 7 days. | Procedure or surgery | Controlled Heat Exposure and Gravimetric Sweat Assessment |
Primary outcome
Total Gravimetric Sweat Production (TGSP)
Time frame: During each of three approximately 30-minute heat-exposure sessions, with sessions at least 1 day apart and all three sessions completed within 7 days.
TGSP is defined as the sum of sweat mass collected from all prespecified and evaluable anatomical sites during a standardized heat-exposure session. For each site, sweat mass is calculated as the post-exposure filter paper weight minus the pre-exposure filter paper weight. TGSP will be reported in milligrams and may also be standardized by filter paper area according to the statistical analysis plan.
13 secondary outcomes
Regional Gravimetric Sweat Production by Anatomical Site
Time frame: During each of three approximately 30-minute heat-exposure sessions, with sessions at least 1 day apart and completed within 7 days.
Test-Retest Reliability of Total Gravimetric Sweat Production
Time frame: Across the three heat-exposure sessions completed within 7 days.
Within-Participant Variability of Total Gravimetric Sweat Production
Time frame: Across the three heat-exposure sessions completed within 7 days.
Test-Retest Reliability and Variability of Regional Sweat Production
Time frame: Across the three heat-exposure sessions completed within 7 days.
Total and Regional Sweat Production by Clinical Group, Sex, and Age Category
Time frame: During the three heat-exposure sessions completed within 7 days.
Sauna Chamber Temperature Stability
Time frame: Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.
Sauna Chamber Relative Humidity Stability
Time frame: Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.
Change in Body Temperature During Controlled Heat Exposure
Time frame: Before, during, immediately after, and during recovery from each of the three heat-exposure sessions completed within 7 days.
Heat-Exposure Sessions Terminated Early Due to Body Temperature of 38.0°C or Higher or Participant Intolerance
Time frame: During the three heat-exposure sessions completed within 7 days.
Incidence, Type, and Severity of Adverse Events and Heat-Related Intolerance Events
Time frame: From initiation of the first study procedure through the follow-up assessment, up to approximately 17 days per participant.
Anhidrosis/Hypohidrosis Impact Questionnaire Total Score
Time frame: Before the first heat-exposure session and 8 to 10 days after the final heat-exposure session.
Change in Anhidrosis/Hypohidrosis Impact Questionnaire Total Score
Time frame: From before the first heat-exposure session to 8 to 10 days after the final heat-exposure session.
Test-Retest Reliability of the Anhidrosis/Hypohidrosis Impact Questionnaire
Time frame: Between the baseline assessment before the first heat-exposure session and the follow-up assessment 8 to 10 days after the final heat-exposure session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for ROSAH Syndrome
RecruitingPhase 1
Evaluating the Safety and Tolerability of Orally Administered DF-003 in ROSAH Syndrome Patients
ROSAH
RecruitingObservational study
Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cell From Subjects With ROSAH Syndrome
Unrecognized Condition
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of ROSAH Syndrome and Anhidrosis, run by The Third Xiangya Hospital of Central South University.
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 12 inclusion and 12 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Total Gravimetric Sweat Production (TGSP) (time frame: During each of three approximately 30-minute heat-exposure sessions, with sessions at least 1 day apart and all three sessions completed within 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.