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

NCT07679074 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-07-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Samphire Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Nirav Shah, MD, MPH · Samphire Group, Inc.

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-01-01
Completion
2027-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679074 on ClinicalTrials.gov