NCT07679074 CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
| NCT ID | NCT07679074 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samphire Group, Inc. |
| Condition | Premenstrual Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-06-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Nirav Shah, MD, MPH
PRINCIPAL INVESTIGATOR
Samphire Group, Inc.
Frequently Asked Questions
Who can join the NCT07679074 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Premenstrual Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07679074 currently recruiting?
Yes, NCT07679074 is actively recruiting participants. Contact the research team at nirav@investigator.alethios.com for enrollment information.
Where is the NCT07679074 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07679074 clinical trial?
NCT07679074 is sponsored by Samphire Group, Inc.. The principal investigator is Nirav Shah, MD, MPH at Samphire Group, Inc.. The trial plans to enroll 50 participants.