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CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life (CREST)

25 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

50

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • San Francisco, California, Stany Zjednoczone, 94105
        • Rekrutacyjny
        • Alethios Digital Research Platform (Decentralized)
        • Główny śledczy:
          • Nirav Shah, MD, MPH
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Urządzenie: Lutea Transcranial Direct Current Stimulation (tDCS) Device
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.
Inne nazwy:
  • Lutea
Behawioralne: Samphire Guided Care Program
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.
Inne nazwy:
  • SGC Program
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.
Behawioralne: Samphire Guided Care Program
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.
Inne nazwy:
  • SGC Program

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient Health Questionnaire-9 (PHQ-9)
Ramy czasowe: 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
Generalized Anxiety Disorder-7 (GAD-7)
Ramy czasowe: 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.
Baseline, Week 6, Week 12
Insomnia Severity Index (ISI)
Ramy czasowe: Baseline, Week 6, Week 12
Within-participant change in ISI total score. Range 0-28; higher scores indicate greater insomnia severity. MCID: 6 points.
Baseline, Week 6, Week 12
WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
Ramy czasowe: 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
Premenstrual Symptoms Screening Tool (PSST)
Ramy czasowe: 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.
Baseline to Week 12
BrainHQ Cognitive Assessment
Ramy czasowe: Baseline to Week 12
Within-participant change in BrainHQ composite cognitive performance score from baseline to end of program.
Baseline to Week 12
Healthcare Resource Utilization (HCRU)
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Pain Numerical Rating Scale (NRS)
Ramy czasowe: 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)
Ramy czasowe: 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
Net Promoter Score (NPS)
Ramy czasowe: 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
Clinical Global Impression of Severity (CGI-S)
Ramy czasowe: Baseline

Clinician-rated impression of overall symptom severity at onboarding consultation.

7-point scale. Administered by contracted women's health clinician. Exploratory.
Baseline
Clinical Global Impression of Improvement (CGI-I)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Samphire Group, Inc.

Śledczy

  • Główny śledczy: Nirav Shah, MD, MPH, Samphire Group, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2027

Ukończenie studiów (Szacowany)

1 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

25 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

1 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SAM-003

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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