AsthmaNCT05850390
Real-time Remote Asthma Monitoring Through Smartphone Voice Analysis
An observational study of Asthma, run by Sonde Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Respiratory-Responsive Vocal Biomarker application
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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.
Read the detailed description
The study aims to investigate whether home-based monitoring of respiratory function in asthma patients using a smartphone-based vocal biomarker platform can improve the level of asthma control. The study will involve 70 patients aged 18 years and above with a primary diagnosis of asthma or allergy with asthma as a comorbidity, with an Asthma Control Test (ACT) score of less than or equal to 19 at baseline. The primary objective of the study is to assess whether vocal biomarker scores can provide asthma patients with real-time objective information on their respiratory function using voice samples recorded on their personal smartphone device.
The secondary objectives of the study include determining whether smartphone apps incorporating vocal biomarker capabilities can improve asthma control, assessing patient engagement with the apps, and examining the impact of the apps on healthcare utilization in asthma patients. Exploratory objectives include determining how the participant's digital health literacy phenotype can assist in creating engagement with asthma management apps and developing care team dashboards for providers to assist in periodic evaluation of patient status using a vocal biomarker platform.
The study will explore voice recordings for potential new machine learning model development to assess whether different vocal biomarker combinations can provide superior respiratory function monitoring ability than the established Respiratory Symptom Risk scores that were developed from cross-sectional asthma data. The primary endpoints of the study are performance-related measures of Respiratory Symptom Risk score, and the secondary endpoints include the proportion of subjects with ACT improvement and the proportion of participants providing voice samples.
The study will be conducted for three months in clinics providing care to asthma patients, typically asthma/allergy clinics. The Sonde Health App will be used to provide vocal biomarker respiratory symptom risk scores to patients on their personal smartphone device and be used for data collection. The findings of the study could help establish whether the same vocal biomarker models can accurately track changes in respiratory function in asthma patients and whether incorporating this capability into smartphone apps can improve the level of asthma control.
- Conditions
- Asthma
- Being tested
- Respiratory-Responsive Vocal Biomarker application
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory-Responsive Vocal Biomarker applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Respiratory-Responsive Vocal Biomarker application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Enrollment through end of month 3
Secondary outcomes (2)
ACT improvement
The proportion of participants with ACT improvement >=3 points
Measured: End of month 1, 2 and 3
RRVB tool engagement
The proportion of participants providing voice samples on =>50% days
Measured: During month 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start14 Dec 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonde Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Sunit P Jariwala, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850390
- Sponsor's protocol ID
- SH2021.ASTHMA01
- Status last verified
- Aug 2023
- First submitted
- 28 Apr 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40986855
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Remote Asthma Monitoring Through Smartphone Voice Analysis
- ClinicalTrials.gov ID
- NCT05850390
- Acronym / sponsor ID
- SH2021.ASTHMA01
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sonde HealthIndustry (pharma, biotech, devices)
- Collaborators
- Montefiore Medical Center
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aims to investigate whether home-based monitoring of respiratory function in asthma patients using a smartphone-based vocal biomarker platform can improve the level of asthma control. The study will involve 70 patients aged 18 years and above with a primary diagnosis of asthma or allergy with asthma as a comorbidity, with an Asthma Control Test (ACT) score of less than or equal to 19 at baseline. The primary objective of the study is to assess whether vocal biomarker scores can provide asthma patients with real-time objective information on their respiratory function using voice samples recorded on their personal smartphone device.
The secondary objectives of the study include determining whether smartphone apps incorporating vocal biomarker capabilities can improve asthma control, assessing patient engagement with the apps, and examining the impact of the apps on healthcare utilization in asthma patients. Exploratory objectives include determining how the participant's digital health literacy phenotype can assist in creating engagement with asthma management apps and developing care team dashboards for providers to assist in periodic evaluation of patient status using a vocal biomarker platform.
The study will explore voice recordings for potential new machine learning model development to assess whether different vocal biomarker combinations can provide superior respiratory function monitoring ability than the established Respiratory Symptom Risk scores that were developed from cross-sectional asthma data. The primary endpoints of the study are performance-related measures of Respiratory Symptom Risk score, and the secondary endpoints include the proportion of subjects with ACT improvement and the proportion of participants providing voice samples.
The study will be conducted for three months in clinics providing care to asthma patients, typically asthma/allergy clinics. The Sonde Health App will be used to provide vocal biomarker respiratory symptom risk scores to patients on their personal smartphone device and be used for data collection. The findings of the study could help establish whether the same vocal biomarker models can accurately track changes in respiratory function in asthma patients and whether incorporating this capability into smartphone apps can improve the level of asthma control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed asthma patients | – | Other: Respiratory-Responsive Vocal Biomarker applicationAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory-Responsive Vocal Biomarker applicationA 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. | Other | Diagnosed asthma patients |
Primary outcome
RRVB monitoring performance vs. PEF
Time frame: Enrollment through end of month 3
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)
2 secondary outcomes
ACT improvement
Time frame: End of month 1, 2 and 3
RRVB tool engagement
Time frame: During month 1, 2, and 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Derived from this study: PubMed 40986855Larsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunit P Jariwala, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Sonde Health at 1 site in United States.
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 11 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RRVB monitoring performance vs. PEF (time frame: Enrollment through end of month 3). 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 NCT05850390, which also lists 1 linked publication.
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 16 Aug 2023.