Premenstrual SyndromeCRESTNCT07679074
CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
An observational study of Premenstrual Syndrome and Premenstrual Dysphoric Disorder, run by Samphire Group, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Dysmenorrhea
- What is being tested?
- Lutea Transcranial Direct Current Stimulation (tDCS) Device and Samphire Guided Care Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults assigned female at birth aged 18-65 residing in the United States, currently employed full-time with employer-provided medical benefits, and reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause that have been present for at least 3 months and are sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zeenia Framroze contact
United States1 site, 1 recruiting
- Recruiting
Alethios Digital Research Platform (Decentralized)
San Francisco, California, 94105
Zeenia Framroze, support@alethios.com
Nirav Shah, MD, MPH
About this study
Official title: 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
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.
Read the detailed description
The CREST study is a prospective, observational, two-group cohort study conducted in a fully decentralized, at-home format. No randomization, blinding, or placebo comparator is employed.
All enrolled participants receive access to the full SGC program, which includes: a clinician-led eligibility assessment at onboarding conducted by a third-party women's health clinician; at-home transcranial direct current stimulation (tDCS) using the Lutea consumer wellness device (for eligible participants who opt in); ongoing support from a Samphire neuromodulation coach; and app-based symptom tracking via the Alethios digital research platform.
Participants are prospectively allocated to one of two groups based on neuromodulation eligibility, device uptake, and adherence: Group A (neuromodulation cohort, target n=35) comprises participants assessed as eligible who accept the device and complete at least 30% of recommended sessions across the 12-week program; Group B (comparison cohort, target n=15) comprises participants who either decline the device or complete fewer than 30% of sessions.
Group allocation is determined retrospectively at Week 12 based on automated device usage logs. Both groups complete identical assessment schedules.
Primary outcomes are work productivity (WPAI subscales) and employee wellbeing (EQ-5D-5L).
Secondary outcomes include PHQ-9, GAD-7, ISI, WPAI, PSST, and BrainHQ cognitive assessment.
Exploratory outcomes include pain NRS, PGIC, NPS, HCRU, optional wearable physiological data, and clinician-rated CGI-S and CGI-I.
All study activities are conducted remotely via the Alethios digital research platform and Samphire mobile application. Electronic informed consent is obtained prior to any study-related data collection.
- Conditions
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Dysmenorrhea, Endometriosis, Perimenopause, Menopause
- Being tested
- Lutea Transcranial Direct Current Stimulation (tDCS) Device, Samphire Guided Care Program
- Keywords
- tDCS, neuromodulation, hormonal health, menstrual symptoms, perimenopause, menopause, PMDD, PMS, work productivity, brain fog, mood, cognitive function, digital health, decentralized clinical trial, guided care
- Medical subject headings
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Dysmenorrhea, Endometriosis, Pelvic Pain, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutea Transcranial Direct Current Stimulation (tDCS) DeviceDevice
Also called Lutea
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.
Samphire Guided Care ProgramBehavioural
Also called SGC 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Neuromodulation Cohort | Participants assessed as eligible for neuromodulation at the clinician onboarding consultation who accept the Lutea device and complete at least 30% of recommended tDCS sessions across the 12-week program. Group A participants receive the full SGC program including clinician consultation, Lutea device, neuromodulation coach support, and app-based symptom tracking. Receives: Device: Lutea Transcranial Direct Current Stimulation (tDCS) Device; Behavioral: Samphire Guided Care Program | |
| Group B - Comparison Cohort | Participants who either decline the Lutea device following the clinician consultation, or who accept the device but complete fewer than 30% of recommended sessions across the 12-week program. Group B participants receive the same SGC program components as Group A excluding substantive neuromodulation engagement. Receives: Behavioral: Samphire Guided Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
Within-participant change in WPAI Overall Work Impairment subscale score from baseline to end of program. Scores range from 0 to 100%, with higher scores indicating greater impairment. A reduction of 7 percentage points or more is considered clinically meaningful.
Measured: Baseline to Week 12
EQ-5D-5L Utility Index Score
Within-participant change in EQ-5D-5L utility index score from baseline to end of program.
Scores range from 0 to 1, with higher scores indicating better health-related quality of life. A change of 0.07 utility units or more is considered clinically meaningful.
Measured: Baseline to Week 12
Secondary outcomes (7)
Patient Health Questionnaire-9 (PHQ-9)
Within-participant change in PHQ-9 total score. Range 0-27; higher scores indicate greater depressive symptom severity. MCID: 5 points.
Measured: Baseline, Week 6, Week 12
Generalized Anxiety Disorder-7 (GAD-7)
Within-participant change in GAD-7 total score. Range 0-21; higher scores indicate greater anxiety symptom severity. MCID: 4 points.
Measured: Baseline, Week 6, Week 12
Insomnia Severity Index (ISI)
Within-participant change in ISI total score. Range 0-28; higher scores indicate greater insomnia severity. MCID: 6 points.
Measured: Baseline, Week 6, Week 12
WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
Within-participant change in WPAI subscale scores for absenteeism (work time missed), presenteeism (impairment while working), and activity impairment (impairment in daily activities). All subscales scored 0-100%; higher scores indicate greater impairment.
Measured: Baseline, Week 6, Week 12
Premenstrual Symptoms Screening Tool (PSST)
Within-participant change in PSST total score across 19 symptom items and 5 functional impact items. Items rated 1-4 (Not at all to Severe); higher scores indicate greater premenstrual symptom burden.
Measured: Baseline to Week 12
BrainHQ Cognitive Assessment
Within-participant change in BrainHQ composite cognitive performance score from baseline to end of program.
Measured: Baseline to Week 12
Healthcare Resource Utilization (HCRU)
Within-participant change in self-reported healthcare contacts (ER visits, specialist consultations, primary care visits, prescription medication changes) related to hormonal health symptoms, assessed using a study-specific questionnaire adapted from MEPS items.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samphire Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nirav Shah, MD, MPH, Principal investigator, Samphire Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679074
- Sponsor's protocol ID
- SAM-003
- Acronym
- CREST
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07679074
- Acronym / sponsor ID
- CREST / SAM-003
- Conditions
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Dysmenorrhea, Endometriosis, Perimenopause, Menopause
- Keywords
- tDCS, neuromodulation, hormonal health, menstrual symptoms, perimenopause, menopause, PMDD, PMS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Samphire Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CREST study is a prospective, observational, two-group cohort study conducted in a fully decentralized, at-home format. No randomization, blinding, or placebo comparator is employed.
All enrolled participants receive access to the full SGC program, which includes: a clinician-led eligibility assessment at onboarding conducted by a third-party women's health clinician; at-home transcranial direct current stimulation (tDCS) using the Lutea consumer wellness device (for eligible participants who opt in); ongoing support from a Samphire neuromodulation coach; and app-based symptom tracking via the Alethios digital research platform.
Participants are prospectively allocated to one of two groups based on neuromodulation eligibility, device uptake, and adherence: Group A (neuromodulation cohort, target n=35) comprises participants assessed as eligible who accept the device and complete at least 30% of recommended sessions across the 12-week program; Group B (comparison cohort, target n=15) comprises participants who either decline the device or complete fewer than 30% of sessions.
Group allocation is determined retrospectively at Week 12 based on automated device usage logs. Both groups complete identical assessment schedules.
Primary outcomes are work productivity (WPAI subscales) and employee wellbeing (EQ-5D-5L).
Secondary outcomes include PHQ-9, GAD-7, ISI, WPAI, PSST, and BrainHQ cognitive assessment.
Exploratory outcomes include pain NRS, PGIC, NPS, HCRU, optional wearable physiological data, and clinician-rated CGI-S and CGI-I.
All study activities are conducted remotely via the Alethios digital research platform and Samphire mobile application. Electronic informed consent is obtained prior to any study-related data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Neuromodulation Cohort | – | Device: Lutea Transcranial Direct Current Stimulation (tDCS) Device, Behavioral: Samphire Guided Care ProgramParticipants assessed as eligible for neuromodulation at the clinician onboarding consultation who accept the Lutea device and complete at least 30% of recommended tDCS sessions across the 12-week program. Group A participants receive the full SGC program including clinician consultation, Lutea device, neuromodulation coach support, and app-based symptom tracking. |
| Group B - Comparison Cohort | – | Behavioral: Samphire Guided Care ProgramParticipants who either decline the Lutea device following the clinician consultation, or who accept the device but complete fewer than 30% of recommended sessions across the 12-week program. Group B participants receive the same SGC program components as Group A excluding substantive neuromodulation engagement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults assigned female at birth aged 18-65 residing in the United States, currently employed full-time with employer-provided medical benefits, and reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause that have been present for at least 3 months and are sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships.
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutea Transcranial Direct Current Stimulation (tDCS) DeviceAlso: LuteaThe 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. | Device | Group A - Neuromodulation Cohort |
| Samphire Guided Care ProgramAlso: SGC ProgramA 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. | Behavioural | Group A - Neuromodulation Cohort, Group B - Comparison Cohort |
Primary outcome
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment
Time frame: Baseline to Week 12
Within-participant change in WPAI Overall Work Impairment subscale score from baseline to end of program. Scores range from 0 to 100%, with higher scores indicating greater impairment. A reduction of 7 percentage points or more is considered clinically meaningful.
EQ-5D-5L Utility Index Score
Time frame: Baseline to Week 12
Within-participant change in EQ-5D-5L utility index score from baseline to end of program. Scores range from 0 to 1, with higher scores indicating better health-related quality of life. A change of 0.07 utility units or more is considered clinically meaningful.
7 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, Week 6, Week 12
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, Week 6, Week 12
Insomnia Severity Index (ISI)
Time frame: Baseline, Week 6, Week 12
WPAI Absenteeism, Presenteeism, and Activity Impairment Subscales
Time frame: Baseline, Week 6, Week 12
Premenstrual Symptoms Screening Tool (PSST)
Time frame: Baseline to Week 12
BrainHQ Cognitive Assessment
Time frame: Baseline to Week 12
Healthcare Resource Utilization (HCRU)
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeenia Framroze contact
Nirav Shah, MD, MPH principal investigator
Samphire Group, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premenstrual Syndrome and Premenstrual Dysphoric Disorder, run by Samphire Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nirav Shah, MD, MPH (6267201547, nirav@investigator.alethios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Productivity and Activity Impairment (WPAI) - Overall Work Impairment (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.