Skin Hydration Sensor for Sickle Cell Disease

Overseen By Manzoor Mohideen, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Enrico Novelli

Disqualifiers: Under 12, Experimental therapies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will validate the diagnostic accuracy of a cutaneous hydration sensor. This sensor will also be evaluated for its feasibility as a point-of-care device for the assessment of hydration status and its potential to guide hydration therapy in patients with sickle cell disease (SCD).

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Skin Hydration Sensor treatment for sickle cell disease?

Research suggests that hydration can reduce the severity of sickle cell disease, and the Skin Hydration Sensor could help monitor and manage hydration levels effectively. This is supported by studies showing that better hydration correlates with reduced painful crises in sickle cell patients. ^{1 2 3 4 5}

Is the Skin Hydration Sensor safe for use in humans?

The Skin Hydration Sensor has been tested on over 200 patients in a dermatology clinic and 16 healthy participants, showing it is noninvasive, reusable, and safe for monitoring skin hydration without any reported safety issues. ^{6 7 8 9 10}

How does the Skin Hydration Sensor treatment for Sickle Cell Disease differ from other treatments?

The Skin Hydration Sensor is unique because it is a noninvasive, wireless device that measures skin hydration and transmits data to a smartphone, unlike traditional treatments that may involve medication or more invasive procedures. This sensor provides a novel way to monitor skin health, which can be particularly useful for managing conditions like Sickle Cell Disease where skin hydration may be a concern. ^{7 8 9 11 12}

Research Team

Enrico Novelli, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals aged 12 or older who have been diagnosed with Sickle Cell Disease, including various genotypes like SS, SC, and others. Participants must be able to give legal consent to all study procedures. Those under 12 or currently in other clinical trials for experimental therapies cannot join.

Inclusion Criteria

I have been diagnosed with Sickle Cell Disease.

Participants that provide legally effective consent to all study procedures

I am 12 years old or older.

Exclusion Criteria

I am under 12 years old.

You are currently participating in another clinical trial testing an experimental treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants' skin hydration is measured at baseline state of health using the Delfin MoistureMeterEpiD hydration sensor.

Approximately 2 hours

1 visit (in-person)

Crisis Assessment

Skin hydration, serum osmolality, hyperadhesion, elongation index, point of sickling, and urine osmolality are measured before and after fluid resuscitation therapy during a vaso-occlusive crisis (VOC) or vaso-occlusive episode (VOE).

Approximately 2 hours per assessment

2 visits (in-person) during VOC or VOE

Follow-up

Participants are monitored for safety and effectiveness after the assessments.

4 weeks

Treatment Details

Interventions

• Skin Hydration Sensor

Trial Overview The trial is testing a new skin hydration sensor designed to accurately assess hydration levels in patients with Sickle Cell Disease. The goal is to see if this sensor can work as an easy-to-use device at the point of care and help guide proper hydration therapy.

Participant Groups

Group I: Skin Hydration Sensor Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Enrico Novelli

Lead Sponsor

Trials

2

Recruited

50+

Enrico M Novelli

Lead Sponsor

Trials

2

Recruited

50+

Findings from Research

A new microfluidic-informatics system was developed to measure vaso-occlusion in sickle cell disease, showing increased occlusion events in patients with the most severe hemoglobin SS type, which helps in assessing disease severity.

The system can also evaluate the impact of hydration on reducing disease severity, suggesting it could be a useful tool for testing therapeutic strategies in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microfluidic-informatics assay for quantitative physical occlusion measurement in sickle cell disease. Zhang, X., Chan, T., Carbonella, J., et al.[2022]

In a study of 16 children with homozygous sickle cell disease followed for an average of 6.8 years, higher rates of painful crises were linked to better red blood cell hydration and deformability, indicating that cellular hydration plays a significant role in vasoocclusive severity.

Both red cell deformability and hemoglobin concentration were found to be independent predictors of painful crisis incidence, suggesting that managing these factors could help in understanding and potentially reducing the frequency of painful episodes in sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of painful crisis in homozygous sickle cell disease: correlation with red cell deformability. Lande, WM., Andrews, DL., Clark, MR., et al.[2021]

The study enrolled 37 participants with sickle cell disease over 6 months, successfully using electronic patient-reported outcomes (ePRO) and actigraphy to monitor pain and activity, revealing significant changes in pain and functionality on days with vaso-occlusive crises (VOCs).

Biomarkers collected during VOCs showed significant alterations compared to baseline values, indicating that these biological changes could help in identifying and assessing VOCs more effectively in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers. Pittman, DD., Hines, PC., Beidler, D., et al.[2021]

A new microfluidics-based electrical impedance sensor has been developed to continuously monitor the sickling and unsickling processes of sickle cells, providing a more convenient and rapid assessment method compared to traditional optical microscopy.

The sensor shows a strong correlation with patients' hematological parameters, such as levels of sickle hemoglobin (HbS) and fetal hemoglobin, indicating its potential as a reliable tool for characterizing abnormal blood rheology in sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Impedance Characterization of Erythrocyte Response to Cyclic Hypoxia in Sickle Cell Disease. Liu, J., Qiang, Y., Alvarez, O., et al.[2020]

The study highlights the need for improved data acquisition methods in sickle cell disease, which affects 90,000 to 100,000 Americans, to enhance diagnosis and treatment accuracy.

The researchers propose a novel approach that combines wearable sensory technology with mobile phone capabilities to create a textile-based data acquisition system specifically designed for monitoring sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Med-vest: A wearable sensory platform. Durfee, RA., Venugopalan, J., Ren, J., et al.[2020]

A newly developed digital multi-wavelength optical sensor allows for continuous and non-invasive measurement of dermal water content, overcoming limitations of traditional methods that are costly and bulky.

This sensor has shown to be more accurate than high-end spectrophotometers in measuring skin hydration, which could aid in monitoring skin health and managing conditions like diabetes and atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Analysis of a Continuous and Non-Invasive Multi-Wavelength Optical Sensor for Measurement of Dermal Water Content. Mamouei, M., Chatterjee, S., Razban, M., et al.[2021]

The new skin hydration sensor (SHS) is a noninvasive and reusable device that accurately measures skin hydration up to 1 mm deep, providing a significant improvement over traditional dermatological tools that only assess superficial layers.

In pilot studies involving patients with various skin conditions, the SHS demonstrated strong diagnostic capabilities and the potential to evaluate the effectiveness of topical treatments, indicating its usefulness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliable, low-cost, fully integrated hydration sensors for monitoring and diagnosis of inflammatory skin diseases in any environment. Madhvapathy, SR., Wang, H., Kong, J., et al.[2022]

The skin hydration sensor (SHS) has been significantly improved, achieving a 135% increase in sensitivity and a 36% increase in repeatability compared to earlier versions, making it a more reliable tool for measuring skin hydration.

Pilot trials involving over 200 patients demonstrated the SHS's practical utility in a dermatology clinic, highlighting its potential for fast and accurate assessments of skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless, Soft Sensors of Skin Hydration with Designs Optimized for Rapid, Accurate Diagnostics of Dermatological Health. Shin, J., Wang, H., Kwon, K., et al.[2023]

The Skicon-200EX device for measuring skin conductance showed a 1.6-fold higher sensitivity compared to the original Skicon-100 model, indicating it may provide more precise measurements of skin hydration.

Both devices correlated well in their measurements, but differences in conductance levels were observed based on the anatomical site tested and the type of probe used, highlighting the importance of specifying the equipment in scientific studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin conductance; validation of Skicon-200EX compared to the original model, Skicon-100. O'goshi, K., Serup, J.[2019]

The study compared the performance of four different skin hydration measurement devices, revealing that the Skicon hygrometer was less sensitive and more variable than the corneometers, particularly on rough skin sites after damage.

The results highlighted the importance of calibrating devices before comparing data, as significant differences were found between the readings of different corneometer models, emphasizing the need for standardized evaluation methods in skin hydration monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of normal and rough human skin hydration in vivo: evaluation with four different instruments. Van Neste, D.[2019]

The U-shaped fiber-optic refractometer effectively estimates the hydration state of human skin, showing a close relationship with skin conductance measured by a high-frequency electrical current.

The study confirms that this optical sensor provides a convenient and easy method for assessing skin hydration, validated through water sorption-desorption tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin hydration state estimation using a fiber-optic refractometer. Takeo, T., Hattori, H.[2018]

The Skin Hydration Sensor Patch (SHSP) demonstrated a strong correlation with the established Corneometer® technique for measuring skin hydration, indicating its efficacy as a reliable tool for self-monitoring skin moisture.

In a study involving 20 women with moderate dry skin, the SHSP effectively tracked significant improvements in skin hydration after applying a glycerol-containing gel, highlighting its potential for practical use in skincare routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin moisture assessment using Hydration Sensor Patches coupled with smartphones via Near Field Communication (NFC). A pilot study with the first generation of patches that allow self-recordings of skin hydration. Flament, F., Galliano, A., Abric, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A microfluidic-informatics assay for quantitative physical occlusion measurement in sickle cell disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The incidence of painful crisis in homozygous sickle cell disease: correlation with red cell deformability. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Electrical Impedance Characterization of Erythrocyte Response to Cyclic Hypoxia in Sickle Cell Disease. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Med-vest: A wearable sensory platform. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Analysis of a Continuous and Non-Invasive Multi-Wavelength Optical Sensor for Measurement of Dermal Water Content. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Reliable, low-cost, fully integrated hydration sensors for monitoring and diagnosis of inflammatory skin diseases in any environment. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Wireless, Soft Sensors of Skin Hydration with Designs Optimized for Rapid, Accurate Diagnostics of Dermatological Health. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Skin conductance; validation of Skicon-200EX compared to the original model, Skicon-100. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative study of normal and rough human skin hydration in vivo: evaluation with four different instruments. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Skin hydration state estimation using a fiber-optic refractometer. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Skin moisture assessment using Hydration Sensor Patches coupled with smartphones via Near Field Communication (NFC). A pilot study with the first generation of patches that allow self-recordings of skin hydration. [2021]