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

25 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

50

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • California
      • San Francisco, California, Verenigde Staten, 94105
        • Werving
        • Alethios Digital Research Platform (Decentralized)
        • Hoofdonderzoeker:
          • Nirav Shah, MD, MPH
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Apparaat: 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.
Andere namen:
  • Lutea
Gedragsmatig: 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.
Andere namen:
  • 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.
Gedragsmatig: 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.
Andere namen:
  • SGC Program

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Health Questionnaire-9 (PHQ-9)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Numerical Rating Scale (NRS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Samphire Group, Inc.

Onderzoekers

  • Hoofdonderzoeker: Nirav Shah, MD, MPH, Samphire Group, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 maart 2027

Studieregistratiedata

Eerst ingediend

25 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 juni 2026

Eerst geplaatst (Werkelijk)

1 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SAM-003

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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