CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life (CREST)
2026년 6월 25일 업데이트: Samphire Group, Inc.
A 12-Week Prospective Cohort Study Evaluating the Efficacy of the Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life in Individuals With Menstrual and Pelvic Health Conditions
This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program
- a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The CREST study is a prospective, observational, two-group cohort study conducted in a fully decentralized, at-home format. No randomization, blinding, or placebo comparator is employed.
All enrolled participants receive access to the full SGC program, which includes: a clinician-led eligibility assessment at onboarding conducted by a third-party women's health clinician; at-home transcranial direct current stimulation (tDCS) using the Lutea consumer wellness device (for eligible participants who opt in); ongoing support from a Samphire neuromodulation coach; and app-based symptom tracking via the Alethios digital research platform.
Participants are prospectively allocated to one of two groups based on neuromodulation eligibility, device uptake, and adherence: Group A (neuromodulation cohort, target n=35) comprises participants assessed as eligible who accept the device and complete at least 30% of recommended sessions across the 12-week program; Group B (comparison cohort, target n=15) comprises participants who either decline the device or complete fewer than 30% of sessions.
Group allocation is determined retrospectively at Week 12 based on automated device usage logs. Both groups complete identical assessment schedules.
Primary outcomes are work productivity (WPAI subscales) and employee wellbeing (EQ-5D-5L).
Secondary outcomes include PHQ-9, GAD-7, ISI, WPAI, PSST, and BrainHQ cognitive assessment.
Exploratory outcomes include pain NRS, PGIC, NPS, HCRU, optional wearable physiological data, and clinician-rated CGI-S and CGI-I.
All study activities are conducted remotely via the Alethios digital research platform and Samphire mobile application. Electronic informed consent is obtained prior to any study-related data collection.
연구 유형
연구 유형
관찰
등록 (추정된)
등록
50
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Nirav Shah, MD, MPH
- 전화번호: 6267201547
- 이메일: nirav@investigator.alethios.com
연구 연락처 백업
- 이름: Zeenia Framroze
- 이메일: support@alethios.com
연구 장소
-
-
California
-
San Francisco, California, 미국, 94105
- 모병
- Alethios Digital Research Platform (Decentralized)
-
수석 연구원:
- Nirav Shah, MD, MPH
-
연락하다:
- Zeenia Framroze
- 이메일: support@alethios.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
Adults assigned female at birth aged 18-65 residing in the United States, currently employed full-time with employer-provided medical benefits, and reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause that have been present for at least 3 months and are sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships.
설명
Inclusion Criteria:
- Self-identified female, aged 18-65 years at the time of enrollment
- Basic English literacy
- Able and willing to provide informed consent electronically
- Residing in the United States
- Reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause (must endorse a minimum of three of the following: irritability, emotional dysregulation, brain fog, fatigue, reduced concentration, sleep disruption, or low mood)
- Symptoms present for at least 3 months and sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships
- Currently in full-time employment with medical benefits as part of compensation package
- Access to a smartphone with internet access compatible with the Samphire mobile application
- Able to safely operate the study device in the home environment
- Willing to complete baseline, mid-program, and end-of-program questionnaires and engage with the 12-week guided care program
Exclusion Criteria:
- Pregnancy, breastfeeding, or actively planning pregnancy during the study period
- History of epilepsy or seizure disorder
- Severe or unstable neurological disease that, in the opinion of the study team, may increase risk or interfere with participation
- Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use
- Active scalp lesions, open wounds, or dermatologic conditions at electrode sites that may interfere with safe device use
- Current diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric condition that would make participation inappropriate, as determined by screening
- Active suicidal ideation, recent suicidal behavior, or clinically significant self-injurious behavior, as determined by participant self-report during screening
- Inability to provide informed consent or safely use the device in the home environment
- Current participation in another interventional neurotechnology or drug study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
2
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Group A - Neuromodulation Cohort
Participants assessed as eligible for neuromodulation at the clinician onboarding consultation who accept the Lutea device and complete at least 30% of recommended tDCS sessions across the 12-week program.
Group A participants receive the full SGC program including clinician consultation, Lutea device, neuromodulation coach support, and app-based symptom tracking.
|
The Lutea device (Samphire Group, Inc.) is an FCC-registered consumer wellness wearable that delivers low-intensity transcranial direct current stimulation (tDCS) targeting the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC).
Sessions are 20 minutes in duration at a recommended frequency of multiple sessions per week, self- administered at home.
The device does not meet the FDA's statutory definition of a medical device; it is intended for general wellness purposes and is not cleared or approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease.
다른 이름들:
A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform.
All participants in both groups receive this program component.
다른 이름들:
|
|
Group B - Comparison Cohort
Participants who either decline the Lutea device following the clinician consultation, or who accept the device but complete fewer than 30% of recommended sessions across the 12-week program.
Group B participants receive the same SGC program components as Group A excluding substantive neuromodulation engagement.
|
A 12-week structured digital health program comprising: clinician-led neuromodulation eligibility assessment and care pathway assignment at onboarding; ongoing neuromodulation coach support; and app-based daily symptom tracking via the Alethios digital research platform.
All participants in both groups receive this program component.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
기간: Baseline to Week 12
|
Within-participant change in WPAI Overall Work Impairment subscale score from baseline to end of program.
Scores range from 0 to 100%, with higher scores indicating greater impairment.
A reduction of 7 percentage points or more is considered clinically meaningful.
|
Baseline to Week 12
|
|
EQ-5D-5L Utility Index Score
기간: Baseline to Week 12
|
Within-participant change in EQ-5D-5L utility index score from baseline to end of program. Scores range from 0 to 1, with higher scores indicating better health-related quality of life. A change of 0.07 utility units or more is considered clinically meaningful. |
Baseline to Week 12
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
기간: Baseline, Week 6, Week 12
|
Within-participant change in PHQ-9 total score.
Range 0-27; higher scores indicate greater depressive symptom severity.
MCID: 5 points.
|
Baseline, Week 6, Week 12
|
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Generalized Anxiety Disorder-7 (GAD-7)
기간: Baseline, Week 6, Week 12
|
Within-participant change in GAD-7 total score.
Range 0-21; higher scores indicate greater anxiety symptom severity.
MCID: 4 points.
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Baseline, Week 6, Week 12
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Insomnia Severity Index (ISI)
기간: Baseline, Week 6, Week 12
|
Within-participant change in ISI total score.
Range 0-28; higher scores indicate greater insomnia severity.
MCID: 6 points.
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Baseline, Week 6, Week 12
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WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
기간: Baseline, Week 6, Week 12
|
Within-participant change in WPAI subscale scores for absenteeism (work time missed), presenteeism (impairment while working), and activity impairment (impairment in daily activities).
All subscales scored 0-100%; higher scores indicate greater impairment.
|
Baseline, Week 6, Week 12
|
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Premenstrual Symptoms Screening Tool (PSST)
기간: Baseline to Week 12
|
Within-participant change in PSST total score across 19 symptom items and 5 functional impact items.
Items rated 1-4 (Not at all to Severe); higher scores indicate greater premenstrual symptom burden.
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Baseline to Week 12
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BrainHQ Cognitive Assessment
기간: Baseline to Week 12
|
Within-participant change in BrainHQ composite cognitive performance score from baseline to end of program.
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Baseline to Week 12
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Healthcare Resource Utilization (HCRU)
기간: Baseline to Week 12
|
Within-participant change in self-reported healthcare contacts (ER visits, specialist consultations, primary care visits, prescription medication changes) related to hormonal health symptoms, assessed using a study-specific questionnaire adapted from MEPS items.
|
Baseline to Week 12
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Numerical Rating Scale (NRS)
기간: Baseline, Week 6, Week 12
|
Within-participant change in average pelvic or menstrual pain over the past 7 days. Scored 0-10; higher scores indicate greater pain severity. MCID: 2 points. Exploratory outcome. |
Baseline, Week 6, Week 12
|
|
Patient Global Impression of Change (PGIC)
기간: Week 12
|
Participant-rated overall impression of change in hormonal health symptoms since study start.
7-point scale from Very much improved (1) to Very much worse (7).
Exploratory.
|
Week 12
|
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Net Promoter Score (NPS)
기간: Week 12, Week 24
|
Participant likelihood to recommend the SGC program.
Scored 0-10.
Exploratory engagement metric for employer-facing reporting.
|
Week 12, Week 24
|
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Clinical Global Impression of Severity (CGI-S)
기간: Baseline
|
Clinician-rated impression of overall symptom severity at onboarding consultation. 7-point scale. Administered by contracted women's health clinician. Exploratory. |
Baseline
|
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Clinical Global Impression of Improvement (CGI-I)
기간: Week 12
|
Clinician-rated impression of overall symptom improvement from baseline to end of program. 7-point scale. Administered by contracted women's health clinician. Exploratory. |
Week 12
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Nirav Shah, MD, MPH, Samphire Group, Inc.
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 (실제)
연구 시작
2026년 6월 1일
기본 완료 (추정된)
기본 완료
2027년 1월 1일
연구 완료 (추정된)
연구 완료
2027년 3월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 25일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 25일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 1일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 25일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- SAM-003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .