Real-time Remote Asthma Monitoring Through Smartphone Voice Analysis

NCT05850390 | Unknown

• 1 other identifier: SH2021.ASTHMA01
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the impact of home-based monitoring of respiratory function in asthma patients via a smartphone-based vocal biomarker platform. Previous work from cross-sectional studies has indicated that brief voice samples, analyzed by machine learning models, can predict the presence of respiratory conditions (asthma, COPD, ILD, COVID-19 and persistent cough) with an accuracy of approximately 70%. The present study seeks to extend these findings to establish whether the same vocal biomarker models can accurately track changes in respiratory function in asthma patients, and whether this capability, when incorporated into a smartphone app similar to those used for home-based asthma management, can improve relative level of asthma control.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• RRVB monitoring performance vs. PEF

  Sensitivity, specificity and odds ratio of RRVB score to identify peak flow scores vs. personal best in green (\>=80%, G), yellow (\>=50%, \<80%, Y) and red zones (\<50%, R)

  Enrollment through end of month 3

Secondary Outcomes (2)

• ACT improvement

  End of month 1, 2 and 3

• RRVB tool engagement

  During month 1, 2, and 3

Study Arms (1)

Diagnosed asthma patients

Adults aged 18 and above who have been diagnosed with persistent asthma or allergy with asthma as a co-morbidity and are prescribed a controller medication.

Other: Respiratory-Responsive Vocal Biomarker application

Interventions

Respiratory-Responsive Vocal Biomarker application OTHER

A smartphone app that allows participants to receive a respiratory-responsive vocal biomarker (RRVB) score by recording a 6-second held "ahh" vowel elicitation. The applications returns the RRVB score which has previously been validated to correspond to the likelihood that the user's voice is similar to those of people diagnosed with asthma. This study will examine if the RRVB scores correlate with respiratory function and symptoms in asthma patients.

Diagnosed asthma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is testing the use of the Sonde Health app in patients with persistent asthma or allergy with asthma as a co-morbidity who are prescribed controller medication. Participants must be 18 or older, speak English, and have an eligible smartphone. Daily peak flow meter readings are required. New or existing patients and pregnant women can participate. No speech disorders, smartphone issues, or end-stage COPD. No ongoing asthma trials.

You may qualify if:

• Own an eligible smartphone (iOS or Android) that is able to download and run the Sonde Health app
• Willing to sign up for a Sonde app account
• Agreement with the subject consent information presented on the Sonde app.
• Stated willingness and ability to comply with all study procedures for the duration of the study
• Male or female, aged 18 or above
• Able to read and speak English (required to follow app instructions and provide correct voice elicitations)
• Pregnant women are allowed to participate
• Have a medical diagnosis of persistent asthma, or allergy with asthma as a co-morbidity, and a prescribed controller medication
• ACT score \<= 19 on day of enrollment
• New or existing patients are eligible
• Asthma and COPD as comorbidities are allowed

You may not qualify if:

• Speech disorder or impediment (clinician judgment)
• Difficulties reading or responding to instructions and questions on a smartphone screen
• End-stage COPD or other condition requiring home oxygen
• Anticipated inability to conduct daily peak flow meter readings at home
• Participation in asthma-focused medication studies or trials

Sponsors & Collaborators

• Sonde Health: lead
• Montefiore Medical Center: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Larsen E, Song X, Joachim D, Ch'en PY, M Green S, Hunt E, Kaur S, Nag R, Pisani O, Thomas S, Adewunmi V, Lutz C, Baghizadeh-Toosi B, Feldman JM, Jariwala S. Respiratory-Responsive Vocal Biomarker for Asthma Exacerbation Monitoring: Prospective Cohort Study. J Med Internet Res. 2025 Sep 23;27:e68741. doi: 10.2196/68741.

  PMID: 40986855 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sunit P Jariwala, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: December 14, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)