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RECRUITING
NCT07679074

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

Sponsor: Samphire Group, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-06-01

Completion Date

2027-03-01

Last Updated

2026-07-01

Healthy Volunteers

Yes

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.

Locations (1)

Alethios Digital Research Platform (Decentralized)

San Francisco, California, United States