URTINCT03169699
Acoustic Analytic Apps for Smart Telehealth Screening - Creating a Big Data
An observational study of URTI and Cough, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
To develop and validate a library of cough spectrum from a target of 1000 cough acoustics. Coughs arising from upper respiratory infection, lower chest infections, asthma, allergic conditions are included in the study. Cough acoustic in absence of respiratory disease is also included. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- URTI, Cough, Cough Variant Asthma
- How many people
- 600 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Feb 2017to 31 Mar 2018
- 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 Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This is a prospective observation cohort study will recruit children below the age of 16 years old. There will be 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) well patient without cough.
Who may be able to join
- Cough arm 1.Children age 16 years old and below with cough at presentation- Patients presenting with active or chronic or residual cough
- Well arm
- 1.Children age 16 years old and below and Well with no cough presentation.
Who cannot join
- Children with severe behavioral
- Droplet isloated cases as determined by protocol of hospital
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KKWCH
Singapore, 229899
Siti Nur Diyanah, 65-63948459 ext. 8459, Siti.Nur.Diyanah@kkh.com.sg
Hwan Ing Hee, 65-63943019 ext. 3019, hee.hwan.ing@singhealth.com.sg
About this study
To develop and validate a library of cough spectrum from a target of 1000 cough acoustics. Coughs arising from upper respiratory infection, lower chest infections, asthma, allergic conditions are included in the study. Cough acoustic in absence of respiratory disease is also included.
This is a prospective observation cohort study recruiting children below the age of 16 years old in 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) Well patients without active coughing.
Read the detailed description
Cough is a common presentation in childhood. It is one of the early symptom of respiratory disease such as upper respiratory tract infection, cough variant asthma, allergic rhinitis, bronchitis and pneumonia. These conditions are common ailments in childhood. The history of cough and description of cough given by caretakers and patients are often vague and assessment of cough quality is often subjective. The quality of cough is often assigned a dichotomous category of dry cough and wet cough.
Computer assisted cough analysis has been developed in recent years to aid subjective classification of cough. The sound spectrum and frequencies of cough is being researched to better define the quality of cough. The quality of cough gives meaningful information about the state of the respiratory status. Cough sound analysis has been shown to rapidly diagnose pneumonia in humans using cough sound analysis and in differentiating wet and dry cough.
The investigators hypothesize that each respiratory pathology will have its spectral cough characteristics. Analysis of cough spectrum and comparing to a library of cough spectra data will be able to aid differentiation of the underlying conditions for the various cough spectrum and hence facilitating management.
The study aim is to develop a computer processing technique of cough sounds and determine their spectral characteristics for the common causes of cough to derive an assisted assay of cough spectrum for an objective assessment of cough.
- Medical subject headings
- Cough, Cough-Variant Asthma, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cough Arm | Children age 16 years old and below with cough at presentation - Patients presenting with active or chronic or residual cough | |
| Well Arm | Children age 16 years old and below and Well with no presentation of cough |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute phase acoustic spectrum Analysis
Acoustic classifiers
Measured: Day 0-7
Secondary outcomes (1)
Recovery or Chronic phase acoustic spectrum analysis
Acoustic classifiers
Measured: Day 7-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Feb 2017
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (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 URTIStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Singapore University of Technology and Design
- Responsible party
- Sponsor
- Investigators
- Hwan Ing Hee, MBBCH BAO, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169699
- Sponsor's protocol ID
- KKWCH 2016/2416
- Status last verified
- May 2017
- First submitted
- 25 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
B T B, Hee HI, Teoh OH, Lee KP, Kapoor S, Herremans D, Chen JM. Asthmatic versus healthy child classification based on cough and vocalised /a:/ sounds. J Acoust Soc Am. 2020 Sep;148(3):EL253. doi: 10.1121/10.0001933.
PubMed 33003873
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Analytic Apps for Smart Telehealth Screening - Creating a Big Data
- ClinicalTrials.gov ID
- NCT03169699
- Acronym / sponsor ID
- KKWCH 2016/2416
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Singapore University of Technology and Design
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 30 May 2017 (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.
To develop and validate a library of cough spectrum from a target of 1000 cough acoustics. Coughs arising from upper respiratory infection, lower chest infections, asthma, allergic conditions are included in the study. Cough acoustic in absence of respiratory disease is also included.
This is a prospective observation cohort study recruiting children below the age of 16 years old in 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) Well patients without active coughing.
Detailed description
Cough is a common presentation in childhood. It is one of the early symptom of respiratory disease such as upper respiratory tract infection, cough variant asthma, allergic rhinitis, bronchitis and pneumonia. These conditions are common ailments in childhood. The history of cough and description of cough given by caretakers and patients are often vague and assessment of cough quality is often subjective. The quality of cough is often assigned a dichotomous category of dry cough and wet cough.
Computer assisted cough analysis has been developed in recent years to aid subjective classification of cough. The sound spectrum and frequencies of cough is being researched to better define the quality of cough. The quality of cough gives meaningful information about the state of the respiratory status. Cough sound analysis has been shown to rapidly diagnose pneumonia in humans using cough sound analysis and in differentiating wet and dry cough.
The investigators hypothesize that each respiratory pathology will have its spectral cough characteristics. Analysis of cough spectrum and comparing to a library of cough spectra data will be able to aid differentiation of the underlying conditions for the various cough spectrum and hence facilitating management.
The study aim is to develop a computer processing technique of cough sounds and determine their spectral characteristics for the common causes of cough to derive an assisted assay of cough spectrum for an objective assessment of cough.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cough Arm | – | –Children age 16 years old and below with cough at presentation - Patients presenting with active or chronic or residual cough |
| Well Arm | – | –Children age 16 years old and below and Well with no presentation of cough |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This is a prospective observation cohort study will recruit children below the age of 16 years old. There will be 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) well patient without cough.
Key inclusion criteria (3 listed)
- Cough arm 1.Children age 16 years old and below with cough at presentation- Patients presenting with active or chronic or residual cough
- Well arm
- 1.Children age 16 years old and below and Well with no cough presentation.
Key exclusion criteria (2 listed)
- Children with severe behavioral
- Droplet isloated cases as determined by protocol of hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute phase acoustic spectrum Analysis
Time frame: Day 0-7
Acoustic classifiers
1 secondary outcome
Recovery or Chronic phase acoustic spectrum analysis
Time frame: Day 7-30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Derived from this study: PubMed 33003873B T B, Hee HI, Teoh OH, Lee KP, Kapoor S, Herremans D, Chen JM. Asthmatic versus healthy child classification based on cough and vocalised /a:/ sounds. J Acoust Soc Am. 2020 Sep;148(3):EL253. doi: 10.1121/10.0001933.
- Individual participant dataSharing planned: Undecided
Related trials for URTI
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Recruiting
Thermal Therapies in the Treatment of Muscle Injuries
Hamstring Injuries, Hamstring Muscle Repair
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.
Hwan Ing Hee, MBBCH BAO principal investigator
KK Women's and Children's Hospital
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 URTI and Cough, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 3 inclusion and 2 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 1 Jun 2017. 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 Singapore. 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?
Contact Hwan Ing Hee, MBBCH BAO (65-81252657, hee.hwan.ing@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute phase acoustic spectrum Analysis (time frame: Day 0-7). 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 NCT03169699, 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 1 Jun 2017.