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

Samphire Group, Inc. · NCT07679074

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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
CREST: Samphire Guided Care Program on Wellbeing, Work… (NCT07679074) | Bored Studies