A Method Characterization Study to Evaluate Thermoregulatory Sweat Production in Healthy Volunteers and Patients With ROSAH Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Total Gravimetric Sweat Production (TGSP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Controlled Heat Exposure and Gravimetric Sweat Assessment
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.
干预措施: Standardized Controlled Heat Exposure With Gravimetric Sweat Collection (Procedure)
结局指标
主要结局
Total Gravimetric Sweat Production (TGSP)
时间窗: 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.
次要结局
- Regional Gravimetric Sweat Production by Anatomical Site(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(Across the three heat-exposure sessions completed within 7 days.)
- Within-Participant Variability of Total Gravimetric Sweat Production(Across the three heat-exposure sessions completed within 7 days.)
- Test-Retest Reliability and Variability of Regional Sweat Production(Across the three heat-exposure sessions completed within 7 days.)
- Total and Regional Sweat Production by Clinical Group, Sex, and Age Category(During the three heat-exposure sessions completed within 7 days.)
- Sauna Chamber Temperature Stability(Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.)
- Sauna Chamber Relative Humidity Stability(Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.)
- Change in Body Temperature During Controlled Heat Exposure(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(During the three heat-exposure sessions completed within 7 days.)
- Incidence, Type, and Severity of Adverse Events and Heat-Related Intolerance Events(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(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(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(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.)
研究者
Guoping Yang
Professor of Clinical Pharmacology
The Third Xiangya Hospital of Central South University