AzTrials
AzTrials

Health and WellnessNCT07832981

Wellness Program Participation and Changes in Health and Quality of Life in Adults and Children

An observational study of Health and Wellness, run by Dr. Goodenowe Research LLC at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this observational study is to learn how health and quality of life change over time in adults and children aged 2 years and older. It will also examine how these changes are related to participation in wellness activities and the use of nutritional supplements. Read more about this study

Who is it for?
Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for
Health and Wellness
How many people
100 participants
Where
2 sitesin 2 countries
Study dates
Sep 2026to Sep 2034
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 2 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Individuals aged 2 years and older, with or without chronic health conditions, may participate. The study population may include individuals who independently participate in a comprehensive wellness program and individuals who do not participate in a wellness program but consent to research-only assessments. Participants will be recruited through program enrollment communications, community outreach, social media, and referrals from health care providers.

Who may be able to join

  • Age 2 years or older
  • Able to provide informed consent, or parent or legally authorized representative able to provide informed consent
  • Able to provide assent, if age 7 years or older
  • Willing and able to complete baseline and follow-up assessments according to the study schedule
  • Willing to allow use of wellness program data for research, if enrolling in a wellness program

Who cannot join

  • Participant or caregiver unable to provide informed consent
  • Expected inability to complete follow-up
  • Concurrent enrollment in an interventional clinical trial that would substantially confound outcomes of interest
  • Any condition that, in the opinion of the investigator, would make participation unsafe or unreliable

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Kaitlyn Hofmeister contact

951-228-4222

k.hofmeister@drgoodenowe.com

2 sites in 2 countries

United States1 site

  • Restorative Health Center

    Temecula, California, 92590

    Dayan Goodenowe, PhD

    Stan Mokoko Sr, MD, MS-CRA

Other trials in United States

Canada1 site

  • Lakeview Regional Wellness Centre

    Moose Jaw, Saskatchewan, S6H 7T2

    Dayan Goodenowe, PhD

Other trials in Canada

About this study

Official title: Association Between Participation in a Comprehensive Wellness Program and Changes in Functional, Nutritional, and Quality of Life Outcomes Among Adults and Children - an Observational Study

The goal of this observational study is to learn how health and quality of life change over time in adults and children aged 2 years and older. It will also examine how these changes are related to participation in wellness activities and the use of nutritional supplements.

The main questions this study aims to answer are:

Read more

How do measures of health, physical function, and quality of life change over time? Are changes in these measures associated with participation in a wellness program, nutritional supplement use, or other health and lifestyle factors?

Participants may:

Answer questions about their health, lifestyle, physical activity, sleep, fatigue, stress, and quality of life.

Complete physical and functional assessments. Choose to provide blood samples for laboratory testing. Complete follow-up assessments over time.

This is an observational study. Researchers will not assign participants to a wellness program or any other intervention or tell participants which supplements to use. Any wellness program participation or supplement use occurs independently of the study.

Keywords
Wellness Program, Nutritional Supplements, Quality of Life, Physical Function, Biomarkers, Lifestyle, Longitudinal Health, Brain Health

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in N100 amplitude measured using the NeuroCatch Platform

    Change from baseline in N100 event-related potential (ERP) amplitude, measured in microvolts (µV) using the NeuroCatch portable electroencephalography (EEG) platform. N100 amplitude represents the magnitude of the electrophysiological response associated with early auditory sensory processing.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  2. Change from baseline in N100 latency measured using the NeuroCatch Platform

    Change from baseline in N100 ERP latency, measured in milliseconds (ms) using the NeuroCatch portable EEG platform. N100 latency represents the timing of the electrophysiological response associated with early auditory sensory processing.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  3. Change from baseline in P300 amplitude measured using the NeuroCatch Platform

    Change from baseline in P300 ERP amplitude, measured in microvolts (µV) using the NeuroCatch portable EEG platform. P300 amplitude represents the magnitude of the electrophysiological response associated with attentional and orienting processing.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  4. Change from baseline in P300 latency measured using the NeuroCatch Platform

    Change from baseline in P300 ERP latency, measured in milliseconds (ms) using the NeuroCatch portable EEG platform. P300 latency represents the timing of the electrophysiological response associated with attentional processing.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  5. Change from baseline in N400 amplitude measured using the NeuroCatch Platform

    Change from baseline in N400 ERP amplitude, measured in microvolts (µV) using the NeuroCatch portable EEG platform. N400 amplitude represents the magnitude of the electrophysiological response associated with higher-order semantic processing.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  6. Change from baseline in N400 latency measured using the NeuroCatch Platform

    Change from baseline in N400 ERP latency, measured in milliseconds (ms) using the NeuroCatch portable EEG platform. N400 latency represents the timing of the electrophysiological response associated with higher-order semantic processing.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  7. Change From Baseline in Heart Rate Recovery Assessed by Electrocardiography

    Change from baseline in heart rate recovery following a standardized physiological challenge will be assessed using electrocardiography (ECG). Heart rate recovery will be calculated as the difference between the heart rate at the end of the challenge and the heart rate measured at a prespecified recovery time point (1 minute) after cessation of the challenge. Heart rate recovery will be reported in beats per minute (bpm). A larger decrease in heart rate during the recovery period indicates faster cardiac autonomic recovery.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  8. Change From Baseline in Body Composition as Measured by the InBody Bioelectrical Impedance Analysis (BIA) System

    Change from baseline in body composition will be assessed using an InBody bioelectrical impedance analysis (BIA) device. Body composition parameters will include percent body fat (%), body fat mass (kg), and skeletal muscle mass (kg). Changes in each parameter will be calculated as the value at the follow-up assessment minus the corresponding baseline value, expressed as a percentage.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  9. Change From Baseline in Forced Expiratory Volume in One Second to Forced Vital Capacity (FEV1/FVC) Ratio as Measured by Spirometry

    Change from baseline in the ratio of Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FEV1/FVC) will be assessed using spirometry. The FEV1/FVC ratio represents the proportion of the total forced vital capacity that is exhaled during the first second of a forced expiratory maneuver and will be expressed as a percentage. Change will be calculated as the follow-up FEV1/FVC value minus the corresponding baseline value and will be expressed as a percentage in relation to the baseline.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  10. Change From Baseline in Hand Grip Strength as Measured by a Handgrip Dynamometer

    Change from baseline in hand grip strength will be assessed using a handgrip dynamometer and reported in kilograms (kg). Hand grip strength represents the maximal voluntary isometric force generated during a handgrip contraction.

    Grip strength will be measured in both the right and left hands. The highest valid grip-strength measurement from three attempts for each hand will be identified. Overall hand grip strength will be calculated as the average of the best right-hand and best left-hand measurements. This averaged value, expressed in kg, will constitute the reported hand grip strength for each assessment. Change from baseline will be calculated as the follow-up overall hand grip strength value minus the baseline overall hand grip strength value and will be expressed as a percentage in relation to the baseline. A positive change indicates increased grip strength, while a negative change indicates decreased grip strength.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  11. Change From Baseline in Timed Up and Go (TUG)

    Change from baseline in functional mobility as assessed using the Timed Up and Go test.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  12. Change From Baseline in Dynamic Gait Index

    Change from baseline in gait and balance as assessed using the Dynamic Gait Index.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  13. Change From Baseline in Symbol Digit Modalities Test

    Change from baseline in cognitive performance as assessed using the Symbol Digit Modalities Test.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  14. Change From Baseline in Distance Visual Acuity as Measured Using a Snellen Visual Acuity Chart

    Change from baseline in distance visual acuity will be assessed using a Snellen visual acuity chart. Visual acuity represents the ability to distinguish letters or symbols at a standardized testing distance and will be recorded as a Snellen fraction (e.g., 20/20). Visual acuity will be assessed according to the study's standardized vision assessment protocol. Change from baseline will be determined by comparing the follow-up visual acuity measurement with the corresponding baseline measurement.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  15. Change From Baseline in Total Physical Activity as Assessed by the International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    Change from baseline in total physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The questionnaire assesses self-reported physical activity performed during the previous 7 days, including walking, moderate-intensity activity, and vigorous-intensity activity. Physical activity will be summarized as total Metabolic Equivalent of Task minutes per week (MET-minutes/week) according to the standardized IPAQ scoring protocol. Total physical activity is calculated from the reported frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity, weighted by their corresponding MET values. Higher MET-minutes/week indicate a greater level of physical activity and are generally considered a more favorable outcome in the context of this wellness study. Change from baseline will be calculated as the follow-up total physical activity score in MET-minutes/week minus the corresponding baseline score.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  16. Change From Baseline in Simple Lifestyle Indicator Questionnaire (SLIQ) Score

    Change from baseline in the Simple Lifestyle Indicator Questionnaire (SLIQ) overall score. The SLIQ is a 12-item questionnaire that assesses five lifestyle domains: diet, physical activity, alcohol consumption, smoking, and stress. The overall SLIQ score ranges from 0 to 10, with higher scores indicating a healthier lifestyle. A positive change from baseline indicates improvement in overall lifestyle.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  17. Change From Baseline in Fatigue Severity Scale (FSS) Score

    Change from baseline in the Fatigue Severity Scale (FSS) score. The FSS is a 9-item self-reported questionnaire that assesses the severity of fatigue and its impact on daily functioning. Each item is rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). The overall FSS score is calculated as the mean of the nine item scores and ranges from 1 to 7. Higher scores indicate greater fatigue severity and therefore a worse outcome. A negative change from baseline indicates an improvement in fatigue severity.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  18. Change From Baseline in 10-Item Perceived Stress Scale (PSS-10) Score

    Change from baseline in the 10-Item Perceived Stress Scale (PSS-10) score. The PSS-10 is a 10-item self-reported questionnaire that assesses the degree to which situations in an individual's life are perceived as stressful. Each item is rated on a 5-point scale from 0 (never) to 4 (very often), with positively worded items reverse scored. Item scores are summed to produce a total score ranging from 0 to 40. Higher scores indicate greater perceived stress and therefore a worse outcome. A negative change from baseline indicates an improvement (reduction) in perceived stress.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  19. Change From Baseline in Participant-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2 (PROMIS-10) Scores

    Change from baseline in the Participant-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2 (PROMIS-10) scores. The PROMIS-10 is a 10-item patient-reported questionnaire assessing global physical, mental, and social health. The measure provides separate Global Physical Health and Global Mental Health summary scores.

    For each summary domain, the raw summed score ranges from 4 to 20 and is converted to a standardized T-score. Global Physical Health T-scores range from 16.2 to 67.7, and Global Mental Health T-scores range from 21.2 to 67.6. Higher T-scores indicate better physical or mental health and therefore a better outcome. A positive change from baseline indicates improvement in global health.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  20. Change From Baseline in World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) Domain Scores

    Change from baseline in the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) domain scores. The WHOQOL-BREF is a 26-item self-reported questionnaire that assesses quality of life across four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Domain scores are transformed to a 0 to 100 scale, with higher scores indicating better quality of life and therefore a better outcome. A positive change from baseline indicates an improvement in quality of life.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  21. Change From Baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Cognitive Function Score (Short form)

    Change from baseline in the Quality of Life in Neurological Disorders (Neuro-QoL) Short Form Cognitive Function score. The Neuro-QoL Cognitive Function measure is a patient-reported assessment of perceived cognitive abilities, including areas such as memory, attention, concentration, and executive functioning. Responses are converted to standardized T-scores, with a reference population mean of 50 and a standard deviation of 10. The minimum and maximum attainable T-scores for short form Neuro-QoL Cognitive Function are 17.3 and 64.2. Higher T-scores indicate better perceived cognitive function and therefore a better outcome. A positive change from baseline indicates improvement in cognitive function.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  22. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score

    Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) global score. The PSQI is a 19-item self-reported questionnaire that assesses sleep quality and sleep disturbances over the past month across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, and the seven component scores are summed to produce a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality and therefore a worse outcome. A negative change from baseline indicates improvement in overall sleep quality.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

Secondary outcomes (2)

  1. Change From Baseline in Serum Phospholipid, Fatty Acid, and Gastrointestinal Tract Acid Levels

    Change from baseline in serum lipid biomarkers measured by mass spectrometry, including ethanolamine phospholipids, DHA ethanolamine phospholipids, choline phospholipids, DHA choline phospholipids, dietary fatty acids (omega-3, omega-6, omega-9, oleic acid [OA], linoleic acid [LA], and arachidonic acid [AA]), and gastrointestinal tract acids (GTAs).

    Changes will be expressed as fold-change relative to baseline. For each biomarker, fold-change is calculated as the serum level at the specified follow-up time point divided by the corresponding baseline level. A fold-change of 1.0 indicates no change from baseline, a value greater than 1.0 indicates an increase from baseline, and a value less than 1.0 indicates a decrease from baseline.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

  2. Change From Baseline in Serum Clinical Chemistry Biomarkers

    Change from baseline in serum clinical chemistry biomarkers measured using the Architect system, including glucose, calcium, blood urea nitrogen (BUN), creatinine, albumin, total protein, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), homocysteine, C-reactive protein (CRP), total iron, triacylglycerols, cholesterol, high-density lipoprotein (HDL), and uric acid.

    Changes will be expressed as fold-change relative to baseline. For each biomarker, fold-change is calculated as the serum level at the specified follow-up time point divided by the corresponding baseline level. A fold-change of 1.0 indicates no change from baseline, a value greater than 1.0 indicates an increase from baseline, and a value less than 1.0 indicates a decrease from baseline.

    Measured: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2034 (estimated)
  4. Study completionSep 2034 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07832981
Sponsor's protocol ID
DGR-202604
Other IDs
Pro00094920
Status last verified
Sep 2026
First submitted
21 Aug 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prokes L, Gorylova M, Cermak Sraitrova K, Nazabal V, Havel J, Nemec P. Arsenic-Doped SnSe Thin Films Prepared by Pulsed Laser Deposition. ACS Omega. 2021 Jun 30;6(27):17483-17491. doi: 10.1021/acsomega.1c01892. eCollection 2021 Jul 13.

    PubMed 34278134

  • Zhang H, Qi G, Wang K, Yang J, Shen Y, Yang X, Chen X, Yao X, Gu X, Qi L, Zhou C, Sun H. Oxidative stress: Roles in skeletal muscle atrophy. Biochem Pharmacol. 2023 Aug;214:115664. doi: 10.1016/j.bcp.2023.115664. Epub 2023 Jun 16.

    PubMed 37331636

  • Hurtado-Torres GF. Comment on: Chocolate Consumption and Risk of Coronary Heart Disease, Stroke, and Diabetes: A Meta-analysis of prospective Studies, Nutrients 2017, 9, 688. Nutrients. 2017 Aug 9;9(8):852. doi: 10.3390/nu9080852.

    PubMed 28792459

  • Day AH , Domarkas J , Nigam S , Renard I , Cawthorne C , Burke BP , Bahra GS , Oyston PCF , Fallis IA , Archibald SJ , Pope SJA . Towards dual SPECT/optical bioimaging with a mitochondrial targeting, 99mTc(i) radiolabelled 1,8-naphthalimide conjugate. Dalton Trans. 2020 Jan 2;49(2):511-523. doi: 10.1039/c9dt04024b.

    PubMed 31844857

  • Sahm F, Kalamarides M. TERT, the target? Neuro Oncol. 2018 Nov 12;20(12):1561-1562. doi: 10.1093/neuonc/noy138. No abstract available.

    PubMed 30272206

  • Jess T, Jensen BW, Andersson M, Villumsen M, Allin KH. Inflammatory Bowel Diseases Increase Risk of Type 2 Diabetes in a Nationwide Cohort Study. Clin Gastroenterol Hepatol. 2020 Apr;18(4):881-888.e1. doi: 10.1016/j.cgh.2019.07.052. Epub 2019 Aug 5.

    PubMed 31394285

  • Yamaguchi-Shinozaki K, Shinozaki K. Transcriptional regulatory networks in cellular responses and tolerance to dehydration and cold stresses. Annu Rev Plant Biol. 2006;57:781-803. doi: 10.1146/annurev.arplant.57.032905.105444.

    PubMed 16669782

  • Tanaka K, Iwata T, Yoshida S, Nishii K, Matsui Y, Sugiyama T, Itami M, Iizasa T. A surgical case of synchronous solitary splenic metastasis from lung squamous cell carcinoma: report of a case and review of the literature. Gen Thorac Cardiovasc Surg. 2020 Aug;68(8):866-870. doi: 10.1007/s11748-019-01275-4. Epub 2019 Dec 16.

    PubMed 31845086

  • Solberg B. From Prenatal Diagnosis to Preterm Infants: A Cultural Guide to Understand Scandinavian Variation. Pediatrics. 2018 Sep;142(Suppl 1):S593-S599. doi: 10.1542/peds.2018-0478L.

    PubMed 30171147

  • Brouwers MC. Electrolyte and Acid-Base Disturbances in Diabetes Mellitus. N Engl J Med. 2015 Dec 17;373(25):2482. doi: 10.1056/NEJMc1511638. No abstract available.

    PubMed 26672866

  • Yakimovich KM, Orland C, Emilson EJS, Tanentzap AJ, Basiliko N, Mykytczuk NCS. Lake characteristics influence how methanogens in littoral sediments respond to terrestrial litter inputs. ISME J. 2020 Aug;14(8):2153-2163. doi: 10.1038/s41396-020-0680-9. Epub 2020 May 18.

    PubMed 32424248

  • Mishra S, Maiti S, Dwadasi BS, Rai B. Realistic microstructure evolution of complex Ta-Nb-Hf-Zr high-entropy alloys by simulation techniques. Sci Rep. 2019 Nov 8;9(1):16337. doi: 10.1038/s41598-019-52170-0.

    PubMed 31704976

  • Jodar E, Artola S, Garcia-Moll X, Uria E, Lopez-Martinez N, Palomino R, Martin V. Incidence and costs of cardiovascular events in Spanish patients with type 2 diabetes mellitus: a comparison with general population, 2015. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001130. doi: 10.1136/bmjdrc-2019-001130.

    PubMed 32747385

  • Smith AD, Refsum H. Homocysteine, B Vitamins, and Cognitive Impairment. Annu Rev Nutr. 2016 Jul 17;36:211-39. doi: 10.1146/annurev-nutr-071715-050947.

    PubMed 27431367

  • Chew EY, Clemons TE, Agron E, Domalpally A, Keenan TDL, Vitale S, Weber C, Smith DC, Christen W; AREDS2 Research Group. Long-term Outcomes of Adding Lutein/Zeaxanthin and omega-3 Fatty Acids to the AREDS Supplements on Age-Related Macular Degeneration Progression: AREDS2 Report 28. JAMA Ophthalmol. 2022 Jul 1;140(7):692-698. doi: 10.1001/jamaophthalmol.2022.1640.

    PubMed 35653117

Questions about this trial

What is this clinical trial studying?

An observational study of Health and Wellness, run by Dr. Goodenowe Research LLC at 2 sites in 2 countries.

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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. 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 Kaitlyn Hofmeister (951-228-4222, k.hofmeister@drgoodenowe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in N100 amplitude measured using the NeuroCatch Platform (time frame: Baseline; monthly through Month 6; Months 9, 12, 18, and 24; and annually thereafter through 5 years.). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07832981, which also lists 20 linked publications.

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 22 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in