Smartphone Evaluation for Airway Diseases

(AWARE Trial)

Recruiting at 1 trial location

Overseen By Juan C Celedón, MD DrPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Acute illness, Chronic illness, others

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

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a smartphone app called AWARE can help monitor airways, detect blockages, and identify flare-ups of airway diseases. Participants include individuals with conditions such as asthma, COPD (a lung disease that makes breathing difficult), cystic fibrosis, and other airway disorders. Healthy individuals without these diseases are also included for comparison. Those with asthma requiring medication or frequent flare-ups, or with a doctor-confirmed diagnosis of COPD or cystic fibrosis, may be suitable for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance airway disease management for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this smartphone evaluation method is safe for assessing airway diseases?

Research shows that smartphone apps are generally safe for managing various airway diseases. For COPD, studies have found that using a smartphone app for self-management can improve health without causing major side effects, indicating the app is well-tolerated.

For asthma, mobile health apps effectively help people manage their symptoms. These apps have not been linked to serious side effects, indicating they are generally safe to use.

In the case of cystic fibrosis, a smartphone app helped detect flare-ups of the disease. The study reported no serious safety issues, suggesting the app was safe for participants.

For other airway diseases, such as those involving ciliary motility disorders or bronchiectasis, smartphone apps have been used to track symptoms. These studies have not shown major safety concerns, suggesting the app is likely safe for these conditions as well.

Overall, research suggests that smartphone apps can be a safe tool for managing various airway diseases, with no major safety issues reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AWARE treatment because it leverages smartphone technology to potentially revolutionize the way airway diseases are managed. Unlike traditional treatments that rely heavily on in-clinic visits and standard medication routines, AWARE uses digital tools for real-time monitoring and personalized management, which could enhance patient engagement and adherence. This approach aims to provide more immediate feedback on symptoms and treatment effectiveness, potentially leading to better disease control and improved quality of life for patients with conditions like asthma, COPD, and cystic fibrosis.

What evidence suggests that this smartphone evaluation is effective for airway diseases?

This trial will evaluate the effectiveness of the AWARE smartphone app for managing various airway diseases. Research has shown that smartphone apps can improve health outcomes for different breathing problems. Participants in this trial with chronic obstructive pulmonary disease (COPD) will use the app, as studies have found that smartphone apps for self-care can lead to better health. Those with asthma will also use the app, which often helps control symptoms and improve quality of life. For participants with cystic fibrosis, the app has proven useful in spotting flare-ups more effectively. Additionally, for other breathing issues like those affecting airway movement and bronchiectasis, mobile health apps are becoming popular for managing symptoms. Overall, digital health tools hold promise in helping manage and monitor breathing problems. ^{1 5 6 7 8}

Who Is on the Research Team?

Erick Forno, MD MPH

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for individuals with airway conditions like Bronchiectasis, Ciliary Motility Disorders, COPD, Cystic Fibrosis, Asthma or a floppy airway. It's also open to healthy people who can serve as controls. Specific eligibility criteria are not provided.

Inclusion Criteria

I am between 8 and 65 years old.

Ability to perform spirometry and oscillometry

Signed informed consent (and assent for children as appropriate)

Exclusion Criteria

I don't have any illnesses that could affect my lung function tests.

Inability or unwillingness to perform AWARE, spirometry, or oscillometry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Testing

Development and improvement of smartphone sensing and machine learning approaches for airway disease diagnosis and lung function estimation

Up to two weeks per subject

Multiple visits (in-person and virtual)

Home Monitoring

Subgroup of subjects perform AWARE at home to evaluate supervised vs unsupervised and in-clinic vs at-home measurements

Up to two weeks

Follow-up

Participants are monitored for safety and effectiveness after the main study activities

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AWARE

Trial Overview

The AWARE (Acoustic Waveform Respiratory Evaluation) study tests if smartphone speakers and microphones can measure airway size, detect blockages, help diagnose airway diseases and spot when the disease gets worse.

How Is the Trial Designed?

Group I: Other Airway Diseases Experimental Treatment 1 Intervention

This group will include subjects with airway ciliary motility disorders, bronchiectasis, and airway malaria. Given variability in the clinical presentation and diagnosis of these conditions, they will be ascertained by physician diagnosis and reviewed by study physician investigators.

Group II: Healthy Controls Experimental Treatment 1 Intervention

This will include generally healthy subjects who do not have any of the airway diseases included in the study, nor other chronic cardiorespiratory or other diseases that may alter lung function or the ability to participate in the study.

Group III: Cystic Fibrosis (CF) Experimental Treatment 1 Intervention

Physician diagnosis based on U.S. CF Foundation guidelines, including signs/symptoms of CF and either a positive sweat chloride test (\>60 mmol/L), or an indeterminate sweat chloride test (30-59 mmol/L) plus two CF-causing CFTR mutations. The study may include subjects with different CFTR mutation classes as well as both on and off CFTR modulators.

Group IV: Chronic Obstructive Pulmonary Disease (COPD) Experimental Treatment 1 Intervention

Physician diagnosis, plus symptoms of COPD per GOLD guidelines, plus post-bronchodilator FEV1/FVC \<0.70 or below the lower limit of normal (LLN) using GLI reference equations.

Group V: Asthma Experimental Treatment 1 Intervention

Physician diagnosis plus at least one of the following in the past year: asthma symptoms that improve with albuterol; prescribed asthma controller medication(s); an acute asthma exacerbation requiring systemic steroids; or an emergency department visit or hospitalization for asthma. Alternatively, report of current asthma symptoms per US NAEPP or Global Initiative for Asthma (GINA) guidelines, plus documentation of bronchodilator response or airway hyperresponsiveness.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

In a study involving 101 children with seasonal allergic rhinitis, adherence to daily symptom recording via a mobile app varied significantly, with 64.4% of participants being highly adherent (recording data on over 80% of days).

The study found that a higher percentage of changes in trend in symptom scores (RTSS, CSMS, and VAS) was associated with highly adherent patients, suggesting that this trend change could serve as a reliable proxy for the quality and accuracy of patient-reported data in managing allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation Parameters of Patient-Generated Data for Digitally Recorded Allergic Rhinitis Symptom and Medication Scores in the @IT.2020 Project: Exploratory Study. Dramburg, S., Perna, S., Di Fraia, M., et al.[2022]

The smartphone app developed for adults with cystic fibrosis (CF) helped reduce the time it took to detect respiratory exacerbations that required antibiotics, with a median detection time of 70 days compared to 141 days in the control group.

While the app did not significantly affect the number of intravenous (IV) antibiotic courses used, it was associated with an increase in oral antibiotic courses, indicating a potential shift in treatment approach rather than a reduction in antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone application for reporting symptoms in adults with cystic fibrosis improves the detection of exacerbations: Results of a randomised controlled trial. Wood, J., Jenkins, S., Putrino, D., et al.[2021]

A study of 626 chronic rhinosinusitis (CRS) patients using the mySinusitisCoach app revealed that nearly half of the patients were uncontrolled in their symptoms, significantly affecting their quality of life, especially in terms of sleep and daily activities.

Patients who had undergone functional endoscopic sinus surgery (FESS) reported lower symptom severity, but those with more than three surgeries did not experience the same benefits, indicating a limit to the effectiveness of surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life assessment of chronic rhinosinusitis patients using mobile technology: The mySinusitisCoach project by EUFOREA. Seys, SF., De Bont, S., Fokkens, WJ., et al.[2021]

A smartphone application designed for asthma self-management significantly improved patients' knowledge about their condition, with scores increasing from an average of 2.43 to 4.3 after using the app (p < 0.001).

The app was well-received by users, achieving a 'good' usability rating from 30 asthma patients, 8 IT specialists, and 2 asthma specialists, indicating its potential effectiveness in helping patients manage their asthma better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Asthma Patients' Self-Management through Smartphone-Based Application: Design, Usability Evaluation, and Educational Intervention. Farzandipour, M., Nabovati, E., Heidarzadeh Arani, M., et al.[2020]

The study introduces a cloud-based wearable IoT aldehyde sensor system designed to monitor environmental factors that can trigger asthma, potentially improving asthma management.

This innovative sensor system allows for real-time data collection and analysis, which can help researchers and patients better understand and manage asthma triggers in their daily environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable IoT Aldehyde Sensor for Pediatric Asthma Research and Management. Li, B., Dong, Q., Downen, RS., et al.[2020]

A mobile platform combining an electronic stethoscope, peak flow meter app, and patient questionnaire effectively screens for asthma and COPD, achieving a high accuracy with an AUC of 0.95 for identifying patients from the general population.

The platform not only identifies asthma and COPD but also distinguishes between the two conditions with even greater accuracy, achieving an AUC of 0.97, making it a promising tool for improving diagnosis in areas with limited access to healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile platform for automated screening of asthma and chronic obstructive pulmonary disease. Chamberlain, DB., Kodgule, R., Fletcher, RR.[2020]

A survey of 360 participants revealed that while many individuals believe mobile apps could help manage allergic respiratory diseases, only a small percentage (2 out of 360) regularly use these apps after downloading them.

The study highlights a significant gap in the effective use of medical apps, with 87.2% of participants never having downloaded an app related to their condition, indicating a need for improved app quality and better patient-targeting strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of mobile apps in allergic respiratory diseases: an Italian multicentre survey report. Lombardi, C., Bonini, M., Passalacqua, G.[2019]

The MASK-air® app's daily visual analog scales (VASs) for monitoring allergic rhinitis symptoms show high intra-rater reliability (ICCs between 0.870 and 0.937), indicating that users can consistently report their symptoms over time.

The VASs also demonstrate moderate to high concurrent validity when compared to established measures like the EQ-5D and CARAT scores, suggesting they are effective tools for assessing the impact of allergic rhinitis on daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity, reliability, and responsiveness of daily monitoring visual analog scales in MASK-air®. Sousa-Pinto, B., Eklund, P., Pfaar, O., et al.[2022]

The MASK initiative, utilizing a mobile app for managing allergic rhinitis and asthma, has been deployed in 23 countries and is available in 16 languages, highlighting its global reach and potential for improving patient self-management.

Key findings from the MASK project indicate that many patients self-medicate and often do not adhere to treatment guidelines, suggesting a need for better patient education and support in managing their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MASK 2017: ARIA digitally-enabled, integrated, person-centred care for rhinitis and asthma multimorbidity using real-world-evidence. Bousquet, J., Arnavielhe, S., Bedbrook, A., et al.[2022]

A study using data from the MASK-air® app involving 17,780 users showed that data-driven combined symptom-medication scores (CSMSs) had moderate-to-strong correlations with established measures of rhinitis impact, indicating their effectiveness in assessing treatment outcomes.

Among the CSMSs evaluated, cluster analysis-based scores demonstrated high accuracy in distinguishing levels of rhinitis control, making them strong candidates for use as primary endpoints in future clinical trials for allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of combined symptom-medication scores for allergic rhinitis. Sousa-Pinto, B., Azevedo, LF., Jutel, M., et al.[2022]

The BREATHE platform is a mobile health framework that integrates various sensors to monitor pediatric asthma, collecting continuous data on health metrics, environmental exposures, and daily activities from 20 participants over a week.

Initial findings suggest that BREATHE can effectively correlate environmental triggers with asthma symptoms, although usability challenges were noted, indicating the need for improvements in user engagement and convenience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomedical REAl-Time Health Evaluation (BREATHE): toward an mHealth informatics platform. Bui, AAT., Hosseini, A., Rocchio, R., et al.[2022]

In a study involving 288 participants with poorly controlled asthma, mobile phone-based monitoring did not show significant improvements in asthma control or self-efficacy compared to traditional paper-based monitoring after six months.

Both monitoring methods resulted in similar rates of acute exacerbations and healthcare costs, but the mobile phone service was more expensive due to telemonitoring costs, making it not cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial. Ryan, D., Price, D., Musgrave, SD., et al.[2023]

A total of 72 mobile applications related to allergic rhinitis were identified, with 54 being unique, indicating a significant interest in digital tools for managing this condition.

Over half of the apps (51.4%) involved physician input in their development, suggesting a focus on credible and reliable information for users, while most apps were free and received an average rating of 3.9 out of 5.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications for Allergic Rhinitis. Zhou, AH., Patel, VR., Baredes, S., et al.[2018]

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