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

Part of paid clinical trials in San Francisco, California.

Sponsor
Samphire Group, Inc.
Study ID
NCT07679074
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Lutea Transcranial Direct Current Stimulation (tDCS) Device — 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.
  • Samphire Guided Care Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Alethios Digital Research Platform (Decentralized)San FranciscoCalifornia94105
Zeenia Framroze
[email protected]
Nirav Shah, MD, MPH (PRINCIPAL_INVESTIGATOR)

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Alethios Digital Research Platform (Decentralized)· San Francisco, CA

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