NCT07679074Recruiting
CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 25 Jun 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Samphire Group, Inc.
- Diseases
- Endometriosis
- NCT number
- NCT07679074
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Jun 2026 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current participation in another interventional neurotechnology or drug study
Other illness
- 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
- 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
Other
- Pregnancy, breastfeeding, or actively planning pregnancy during the study period
- Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alethios Digital Research Platform (Decentralized) Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.