Evaluation of a Novel Self-Sampling Earwax Tool for Chronic Disease Biomarkers [TREARS STUDIES II]

NCT06932601 | Not Yet Recruiting

• 1 other identifier: TREARS-II-2025-CL
• Study Type: observational
• Target: 258
• Locations: 0 countries
• Sites: N/A

Brief Summary

Trears Biomarkers: A New Way to Manage Chronic Diseases Trears Biomarkers are changing how we care for chronic diseases by focusing on patients' needs. People with chronic conditions often experience long-lasting changes in their bodies that typical tests do not accurately capture because they mostly measure short-term levels. These tests can be inconvenient, as patients frequently must travel to clinics, and some methods, like using needles, can be painful. The Trears device, on the other hand, is easy and safe for people to use at home. It lets patients take their earwax samples, which they can send to the lab by regular mail, avoiding the hassle of mailing blood samples. This device could even make diagnosing diabetes more accurate. Trears Biomarkers also investigates whether measuring sodium (salt) levels in earwax may be more reliable than a single blood pressure check and more straightforward than using a 24-hour blood pressure monitor. The aim is to enhance the diagnosis of all primary chronic conditions associated with Metabolic Syndrome (MetS), including diabetes, high cholesterol, obesity, and high blood pressure. These conditions are increasingly prevalent and already impact many people worldwide. With just one use, the Trears "multiplex" device could confirm a diagnosis typically requiring multiple tests. Long-term lifestyle changes, like a healthy diet and regular exercise, work better than many drugs for treating MetS. Since the Trears device measures levels that change over time, it can give doctors a better picture of what's happening in a patient's body, allowing for more personalised recommendations. For instance, providing specific dietary advice could be more effective than simply prescribing medication, as it may lead to more lasting improvements in weight and blood pressure. The device's design makes it accessible for home use, including by post, as earwax's natural bacteriostatic properties help preserve sample quality during mailing. In this study, we will test how effectively the Trears device works for diagnosing different types of diabetes and whether it can accurately track long-term levels of MetS markers. The device's new "multiplex" version might also support future point-of-care (POC) testing, allowing for the quick and convenient measurement of all MetS markers. We will consider how lifestyle factors - such as regular earplug use - might affect sample quality, ensuring the technology remains accurate and inclusive across diverse users. If necessary, we will introduce any potential changes in the Trears device design and/or marketing strategy after carefully considering feedback from our patients and their families, as outlined in Trears's mandate. Additionally, we will conduct an economic analysis to determine whether introducing the Trears device to a broader audience is financially sensible and essential. This will strengthen our position when launching our revolutionary technology in a conservative market.

Conditions

Metabolic Syndrome; Diabetes; Hypertension; Obesity and Obesity-related Medical Conditions

Keywords

Trears; Earwax; Chronic Diseases; Long-Term & Continuous levels.; Self-Sampling Test

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of self-sampled earwax glucose for diabetes and glucose intolerance detection

  This primary outcome assesses the sensitivity and specificity of self-sampled earwax glucose levels, measured in a central lab, in identifying individuals with diabetes and glucose intolerance. These will be compared against standard diagnostic methods including the Oral Glucose Tolerance Test (OGTT), HbA1c, capillary POC glucose, and Continuous Glucose Monitoring (CGM) across a 90-day period. Diagnostic performance metrics (sensitivity, specificity, PPV, NPV) will be calculated. The hypothesis is that earwax glucose will yield ≥85% sensitivity and ≥90% specificity compared to OGTT, with variability \<5% and higher predictive accuracy than HbA1c.

  Baseline sampling with reference tests conducted within a ±5-day window

Secondary Outcomes (1)

• Correlation between earwax sodium concentration and chronic blood pressure

  Single sampling at baseline; blood pressure history from past 3 months

Other Outcomes (1)

• Correlation between earwax lipid concentrations (HDL, LDL, TG) and serum lipid profiles

  Single sample collection with serum lipid panel obtained within ±5 days

Study Arms (2)

Metabolic Syndrome Group

Participants with one or more diagnosed components of Metabolic Syndrome, such as hypertension, type 2 diabetes mellitus, dyslipidemia, or central obesity. No intervention is administered. Participants undergo non-invasive collection of earwax samples via a self-sampling device for sodium and other biomarker analysis. The aim is to assess the diagnostic value of earwax-based biomarkers compared with standard clinical reference measures.

Healthy Control Group

Participants without any clinical diagnosis of metabolic syndrome or related chronic diseases. These individuals are used as baseline controls for comparison in the biomarker analysis. Earwax samples are collected using the same self-sampling method to evaluate sodium and other components. No treatment or intervention is provided.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 75 years residing in Chile, recruited from Universidad del Desarrollo's primary care network, including Hospital Padre Hurtado and affiliated outpatient centers. The population includes individuals at risk for metabolic syndrome-defined by BMI ≥25 kg/m² and one or more ADA criteria risk factors-as well as healthy controls. Recruitment is stratified by earwax type and metabolic risk. No randomization will be applied

You may qualify if:

• \- i.People older than 35 years old ii.First-degree relative \[parents or siblings\] with diabetes. iii.Latin \[Chilean\] nationality iv.Women with a previous history of gestational diabetes or delivering a macrosomic (\>9lb) baby v.Overweight or obese \[BMI greater than or equal to 25 kg/m2\] vi.Physical inactivity (no work-, transport-, or recreation-related physical activity in a typical week) vii.BP ≥130 and/or ≥80 mm Hg or use of antihypertensive medication viii.Self-reported diagnosis of prediabetes IFG, IGT or borderline diabetes. ix.Self-reported history of CVD: myocardial infarction, coronary heart disease, or stroke.
• x.HDL-cholesterol \< 35 mg/dL, triglycerides \> 250 mg/dL, or lipid-lowering medication use xi.Women with polycystic ovarian syndrome xii.People with conditions associated with insulin resistance, such as acanthosis nigricansxiii.
• Have non-alcoholic fatty liver disease.

You may not qualify if:

• Participants with any ear disease, including external or internal otitis; Meniere syndrome or any form of dizziness; vertigo; malformation of the external ear; tinnitus; impacted earwax; current or previously perforated eardrums; individuals with tubes in their ears or who have had mastoid surgery; hearing loss or deafness, due to excess earwax production.
• Asian ethnicity or intellectual disabilities due to their differences in the type and amount and type of earwax, respectively (Nussinovitch et al., 2004b; Pata et al., 2003).
• This study will exclude people with very high blood glucose (blood sugar) levels \[greater than or equal to 200 mg/dl\] or with classic symptoms of high blood glucose.
• Individuals with extreme ages under 18 years of age and over 75 years due to their different physiological responses and higher risk profiles.
• Participants with hemoglobinopathies, anaemia, reticulocytosis, blood loss, transfusions, chronic renal or liver disease, high-dose vitamin C, or erythropoietin treatment (Nathan et al., 2007) will also be excluded (Nathan et al., 2007; Weatherall, 2011).
• Individuals with a phobia of needles
• Presence of infection or acute metabolic complications of diabetes, such as ketoacidosis or hyperosmolar state (coma).
• Individuals with existing cardiovascular conditions (e.g., coronary artery disease, heart failure, arrhythmias) may be at increased risk of adverse events (e.g., arrhythmias, hypertensive crises) during salt and fat loading.
• Individuals with morbid obesity (e.g., BMI \> 40 kg/m²) if not safely manageable within the study protocols.
• Current or heavy smokers, e.g. 20 or more cigarettes per day, due to the cardiovascular and metabolic impact of tobacco.
• Individuals who abuse alcohol or any illicit substance due to their potential impact on liver and kidney function, electrolyte balance, and blood pressure regulation.
• Participants adhering to strict dietary regimens (e.g., ketogenic diet, vegetarianism) may have atypical metabolic responses to high-fat and high-salt intake.
• Individuals with existing renal diseases, e.g. Chronic Kidney Disease (CKD) stages 3-5 (eGFR \<60 mL/min/1.73m²), history of acute kidney injury, nephrotic syndrome or significant proteinuria.
• Individuals with recent illness or hospitalisation.
• Current users of loop diuretics, thiazides, or potassium-sparing diuretics. insulin or oral hypoglycaemic agents, statins and other lipid-lowering drugs

Sponsors & Collaborators

• Trears: lead
• Universidad del Desarrollo: collaborator
• Hospital Padre Hurtado: collaborator

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• Nieto-Martinez R, Mechanick JI, Gonzalez-Rivas JP, Ugel E, Iglesias R, Clyne M, Grekin C. Revised Case Finding Protocol for Dysglycemia in Chile: A Call for Action in Other Populations. Endocr Pract. 2023 Aug;29(8):637-643. doi: 10.1016/j.eprac.2023.04.010. Epub 2023 Jun 1.

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Related Links

• Trears Studies II Project
• Trears Device Instructions for Use

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus; Hypertension; Obesity; Chronic Disease

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Manuel Espinoza, B.Sc. M.D Msc. Ph.D.

  Pontificia Universidad Catolica de Chile

  STUDY CHAIR

Central Study Contacts

Andrés Herane-Vives, B.Sc. M.D PGDip M.Phil. Ph.D.

CONTACT

+447586578989; andres.herane@trears.com

Myka Asong

CONTACT

myka.asong@trears.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04