A Method Characterization Study to Evaluate Thermoregulatory Sweat Production in Healthy Volunteers and Patients With ROSAH Syndrome)
2026년 9월 9일 업데이트: Guoping Yang, The Third Xiangya Hospital of Central South University
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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Gravimetric Sweat Production (TGSP)
기간: 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.
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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.
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Regional Gravimetric Sweat Production by Anatomical Site
기간: During each of three approximately 30-minute heat-exposure sessions, with sessions at least 1 day apart and completed within 7 days.
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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.
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During each of three approximately 30-minute heat-exposure sessions, with sessions at least 1 day apart and completed within 7 days.
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Test-Retest Reliability of Total Gravimetric Sweat Production
기간: Across the three heat-exposure sessions completed within 7 days.
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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.
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Across the three heat-exposure sessions completed within 7 days.
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Within-Participant Variability of Total Gravimetric Sweat Production
기간: Across the three heat-exposure sessions completed within 7 days.
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Within-participant variability in TGSP across the three sessions will be summarized using within-participant standard deviation and coefficient of variation.
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Across the three heat-exposure sessions completed within 7 days.
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Test-Retest Reliability and Variability of Regional Sweat Production
기간: Across the three heat-exposure sessions completed within 7 days.
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Test-Retest Reliability and Variability of Regional Sweat Production
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Across the three heat-exposure sessions completed within 7 days.
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Total and Regional Sweat Production by Clinical Group, Sex, and Age Category
기간: During the three heat-exposure sessions completed within 7 days.
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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.
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During the three heat-exposure sessions completed within 7 days.
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Sauna Chamber Temperature Stability
기간: Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.
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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.
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Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.
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Sauna Chamber Relative Humidity Stability
기간: Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.
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Sauna chamber relative humidity will be recorded continuously or at protocol-defined frequent intervals and summarized descriptively to characterize environmental consistency across sessions.
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Throughout each approximately 30-minute heat-exposure session during the three sessions completed within 7 days.
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Change in Body Temperature During Controlled Heat Exposure
기간: Before, during, immediately after, and during recovery from each of the three heat-exposure sessions completed within 7 days.
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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.
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Before, during, immediately after, and during recovery from each of the three heat-exposure sessions completed within 7 days.
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Heat-Exposure Sessions Terminated Early Due to Body Temperature of 38.0°C or Higher or Participant Intolerance
기간: During the three heat-exposure sessions completed within 7 days.
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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.
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During the three heat-exposure sessions completed within 7 days.
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Incidence, Type, and Severity of Adverse Events and Heat-Related Intolerance Events
기간: From initiation of the first study procedure through the follow-up assessment, up to approximately 17 days per participant.
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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.
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From initiation of the first study procedure through the follow-up assessment, up to approximately 17 days per participant.
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Anhidrosis/Hypohidrosis Impact Questionnaire Total Score
기간: Before the first heat-exposure session and 8 to 10 days after the final heat-exposure session.
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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.
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Before the first heat-exposure session and 8 to 10 days after the final heat-exposure session.
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Change in Anhidrosis/Hypohidrosis Impact Questionnaire Total Score
기간: From before the first heat-exposure session to 8 to 10 days after the final heat-exposure session.
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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.
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From before the first heat-exposure session to 8 to 10 days after the final heat-exposure session.
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Test-Retest Reliability of the Anhidrosis/Hypohidrosis Impact Questionnaire
기간: 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.
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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.
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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.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Spearman Correlation Between Baseline Anhidrosis/Hypohidrosis Impact Questionnaire Total Score and Mean Total Gravimetric Sweat Production (TGSP)
기간: Baseline questionnaire assessment before the first heat-exposure session and TGSP measurements from the three heat-exposure sessions completed within 7 days.
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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.
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Baseline questionnaire assessment before the first heat-exposure session and TGSP measurements from the three heat-exposure sessions completed within 7 days.
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Patient-Reported Change in Heat Tolerance
기간: At the follow-up assessment 8 to 10 days after the final heat-exposure session.
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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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At the follow-up assessment 8 to 10 days after the final heat-exposure session.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 15일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 8월 31일
QC 기준을 충족하는 최초 제출
2026년 9월 9일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 9일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DF-GSP-1001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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아니
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