The use of a smartphone app to detect changes in health from voice recordings of people with cystic fibrosis
| ISRCTN | ISRCTN49949826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49949826 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 289665 |
| Protocol serial number | P02706, IRAS 289665 |
| Sponsor | Royal Papworth NHS Foundation Trust |
| Funders | Cystic Fibrosis Trust, LifeArc |
- Submission date
- 05/05/2023
- Registration date
- 15/08/2023
- Last edited
- 19/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Sonde Health is a health technology company with a platform that provides voice-enabled health detection and monitoring capabilities for brain, respiratory and muscular impairment. Analysis of vocal biomarkers can give early insight into health and wellness. Sonde enables most companies and developers with Android or iOS mobile applications to integrate health condition detection and monitoring capabilities powered by voice.
Royal Papworth Hospital has demonstrated that daily recordings of a range of physiological parameters (e.g. spirometry, pulse oximetry, activity, heart rate, etc) in combination with self-reported survey responses (e.g. general wellness, cough, sleep quality) in people with cystic fibrosis (CF) holds promise to more accurately track fluctuations in health condition, in particular the start of pulmonary exacerbations. These data are collected remotely at the study participant’s home using remote/virtual online tools, as part of a larger effort to take a more virtual approach to clinics. Smartphone-based collection of voice samples for vocal biomarker analysis is a natural extension of this approach.
The aim of this study is to explore the potential of vocal biomarkers to assist in or improve the detection of health conditions in people with CF. The emphasis is on identifying the onset and progression of pulmonary exacerbations.
Who can participate?
Patients who are 18 years old or over who have a diagnosis of cystic fibrosis, are able to perform home monitoring and are already using the Project Breathe remote monitoring kit
What does the study involve?
Participants will be asked to do a daily voice recording of an 'ahhh' sound twice into an app downloaded onto a personal smartphone. They will also need to continue to use the Project Breathe home monitoring kit, which includes weighing scales, lung function spirometer, activity watch and recording self-reported measures of coughing and wellness. Participants will be enrolled for 1 year and it will have no impact on usual care.
What are the possible benefits of participating?
There are no potential immediate benefits to taking part but if the study proves successful it has the potential to improve the early diagnosis of pulmonary exacerbations at home. There are no known risks to taking part.
Where is the study run from?
Royal Papworth NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2021 to December 2026
Who is funding the study?
1. Cystic Fibrosis Trust (UK)
2. LifeArc (UK)
Who is the main contact?
Prof. Andres Floto, arf27@cam.ac.uk
Contact information
Principal investigator
Royal Papworth Hospital
Papworth Road
Cambridge
CB2 0AY
United Kingdom
 ORCID ID |
0000-0002-2188-5659 |
|---|---|
| Phone | +44 (0)1223 638000 |
| arf27@cam.ac.uk |
Public
Royal Papworth Hospital
Papworth Road
Cambridge
CB2 0AY
United Kingdom
| ORCID ID |
0000-0002-5697-810X |
|---|---|
| Phone | +44 (0)1223638000 |
| lucy.gale1@nhs.net |
Scientific
Royal Papworth Hospital
Papworth Road
Cambridge
CB2 0AY
United Kingdom
| Phone | +44 (0)1223 638000 |
|---|---|
| lucy.gale1@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational prospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | VOICE-CF: Vocal Biomarker Analysis for Health Condition Detection in People with Cystic Fibrosis |
| Study acronym | VOICE-CF |
| Study objectives | The aim of this study is to explore the potential of vocal biomarkers to assist in or improve the detection of health conditions in people with cystic fibrosis. The emphasis is on identifying the onset and progression of pulmonary exacerbations and to evaluate whether daily respiratory symptom risk monitoring can assist the remote care of patients with cystic fibrosis. |
| Ethics approval(s) | Approved 19/02/2021, North East - Newcastle & North Tyneside 1 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048285; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 21/NE/0013 |
| Health condition(s) or problem(s) studied | Cystic fibrosis |
| Intervention | Participants will complete two daily voice recordings on the Sonde app using a personal smartphone. Each daily voice sample will take approximately 1 minute to complete a 6-second held vowel “ahhh.” Participants will also continue with usual home monitoring such as weight, lung function, activity and self-reported measures as part of the Project Breathe study. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sonde smartphone app |
| Primary outcome measure(s) | The accuracy of the Sonde predictive algorithm to predict when antibiotics will be required to treat an acute pulmonary exacerbation. This will be from the sensitivity and specificity of the predictive algorithm when compared to the Project Breathe predictive algorithm over a 12-month period. |
| Key secondary outcome measure(s) | The accuracy of the Sonde predictive algorithm to substitute for spirometry and pulse oximetry. This will be from the sensitivity and specificity of the Sonde predictive algorithm when compared to spirometry and pulse oximetry over a 12-month period. |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 41 |
| Key inclusion criteria | 1. Diagnosis of cystic fibrosis based on genetic testing and/or sweat chloride levels 2. Age between >/= 18 to </= 65 years of age at time of consent 3. Able to provide written informed consent 4. Patients who are currently undertaking home monitoring/virtual clinics 5. Patients who have the use of a smartphone |
| Key exclusion criteria | 1. Patients unable to provide written informed consent 2. Patients who are currently not undertaking home monitoring/virtual clinics 3. Lung transplant recipients |
| Date of first enrolment | 21/06/2021 |
| Date of final enrolment | 25/02/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cambridge Biomedical Campus
Cambridge
CB2 0AY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. The datasets generated and/or data analysed during the current study are not expected to be made available until the end of all of the home monitoring studies that are currently underway/planned by this group. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 3.0 | 19/03/2021 | 17/05/2023 | No | No |
Additional files
Editorial Notes
19/12/2024: The intention to publish date was changed from 31/12/2025 to 31/12/2026.
18/12/2024: The overall study end date was changed from 31/12/2024 to 31/12/2026.
19/01/2024: The following changes were made:
1. The overall study end date was changed from 01/12/2022 to 31/12/2024.
2. The intention to publish date was changed from 25/02/2024 to 31/12/2025.
20/09/2023: A link to the HRA research summary was added.
17/05/2023: Study's existence confirmed by the Royal Papworth NHS Foundation Trust.
