CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
Samphire Group, Inc. · NCT07679074
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · Women only
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 50
- US sites recruiting
- 1
- Study start
- June 1, 2026
- Record last updated
- July 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Lutea Transcranial Direct Current Stimulation (tDCS) Device; Samphire Guided Care Program
Conditions: Premenstrual Syndrome; Premenstrual Dysphoric Disorder; Dysmenorrhea; Endometriosis; Perimenopause; Menopause; Pelvic Pain
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Alethios Digital Research Platform (Decentralized)
San Francisco, CA 94105
Site contact: Zeenia Framroze · support@alethios.com
Study contacts (from the official record)
- Nirav Shah, MD, MPH · 6267201547 · nirav@investigator.alethios.com
- Zeenia Framroze · support@alethios.com
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