CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
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 studied
Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Dysmenorrhea, Endometriosis, Perimenopause, Menopause, Pelvic Pain
About this study
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.
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.
Primary outcomes
- Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment (Baseline to Week 12)
- EQ-5D-5L Utility Index Score (Baseline to Week 12)
Eligibility information
Study locations
- Alethios Digital Research Platform (Decentralized), San Francisco, California 94105 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.