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NCT07814209

A Method Characterization Study to Evaluate Thermoregulatory Sweat Production in Healthy Volunteers and Patients With ROSAH Syndrome)

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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. 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.

Official title: A Method Characterization Study to Evaluate Thermoregulatory Sweat Production in Healthy Volunteers and Patients With ROSAH Syndrome

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-15

Completion Date

2027-12-31

Last Updated

2026-09-10

Healthy Volunteers

Yes

Conditions

ROSAH Syndrome Anhidrosis Hypohidrosis

Interventions

PROCEDURE

Standardized Controlled Heat Exposure With Gravimetric Sweat Collection

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.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.