Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2025-09-10
2026-02-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants will respond to daily and weekly questionnaires regarding mood, stress, sleep, energy/fatigue, and burnout. Each week, participants will complete consolidated online questionnaires (intended to last no longer than 15 minutes) comprised of the Perceived Stress Short-Form (PSS-4), Well-Being Index (WHO-5), Mini-Z Burnout (5-item), PROMS Sleep Disturbance (PROMIS-SD), GAD-7 (every 2 weeks), and Perceived Stress (PSS-10; monthly). The PSS-10 will replace the PSS-4 on Days 0, 28, and 56.
No tAN treatment will be delivered during the Baseline Period (days between Study Introduction and Day 0). Participants will complete the weekly set of questionnaires ("Weekly Questionnaires") on Day 0. Participants will be recommended to complete the daily set of questionnaires ("Daily Questionnaires ") on the other days of the Baseline Period.
On Days 1 - 28, participants will self-administer one session of one to two hours of tAN therapy each day. Participants will be recommended to complete the daily tAN session post-shift prior to sleep. Weekly Questionnaires will be completed by participants on Study Days 0, 7, 14, 21, 28, 35, 42, 49, and 56. Participants will be recommended to complete Daily Questionnaires on all other study days, up to Day 28. Daily Questionnaires will not be required to be completed by participants. Daily tAN sessions and Daily Questionnaires will cease after Day 28. Participants will complete a Study Satisfaction Questionnaire with the Weekly Questionnaires on Day 56.
Following Day 56, participants will schedule a Study Exit Interview with the Research Coordinator.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active tAN
First responders will self-administer once-daily active tAN sessions for 1-2 hours for 28 days. Participants will complete daily and weekly assessments to evaluate levels of stress, mood, energy/fatigue, sleep quality , and burnout. Daily assessments and tAN sessions will cease after Day 28. Participants will continue to complete weekly assessments until Day 56.
Sparrow Link
Sparrow Link will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. Participants will self-administer daily active tAN sessions on Days 1 - 28.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sparrow Link
Sparrow Link will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. Participants will self-administer daily active tAN sessions on Days 1 - 28.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 18 years
3. Reliable access to an internet-enabled device to complete required questionnaires
4. GAD-7 score ≥ 5
Exclusion Criteria
2. Participant has a history of neurologic diseases or traumatic brain injury
3. Participant has presence of devices (e.g., pacemakers, cochlear prostheses or implants, neurostimulators)
4. Participant has abnormal left ear anatomy or ear infection present
5. Participant has auditory impairment of the left ear (ruptured eardrum, deafness, tinnitus, etc.)
6. Participant is currently enrolled in another interventional trial
7. Women of childbearing potential, not using adequate contraception as per the investigator's judgement
8. Females who are pregnant or lactating
9. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Spark Biomedical, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Navid Khodaparast, PhD
Role: PRINCIPAL_INVESTIGATOR
Spark Biomedical, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Spark Biomedical - DECENTRALIZED STUDY
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kimi Harada
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SBM-MRES-01
Identifier Type: -
Identifier Source: org_study_id