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.
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.
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.
Single group
Standardized Controlled Heat Exposure With Gravimetric Sweat Collection
Procedure/SurgeryParticipants 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.
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.
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.
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.
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.
Test-Retest Reliability and Variability of Regional Sweat Production
Test-Retest Reliability and Variability of Regional Sweat Production
Spearman Correlation Between Baseline Anhidrosis/Hypohidrosis Impact Questionnaire Total Score and Mean Total Gravimetric Sweat Production (TGSP)
Spearman correlation will be used to assess the relationship between the Anhidrosis/Hypohidrosis Impact Questionnaire total score and Total Gravimetric Sweat Production (TGSP). The questionnaire includes 6 scored items, each rated from 0 to 4, yielding a total score of 0 to 24 points; higher scores indicate greater heat intolerance or impact of impaired sweating. TGSP is measured using a gravimetric filter-paper method and is defined as the sum of post-exposure minus pre-exposure filter-paper weights across all evaluable anatomical sites, expressed in milligrams (mg). The outcome will be reported as Spearman's rho, ranging from -1 to +1.
Patient-Reported Change in Heat Tolerance
The change-impression item will be summarized by response category and may be encoded from -3 (very much worse) to +3 (very much improved). In this nontherapeutic study, the item should refer to change since the previous questionnaire assessment rather than change since starting treatment.
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The Third Xiangya Hospital of Central South University
Lead sponsor
Drug Farm Inc
Collaborator
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