Acoustic Analytic Apps for Smart Telehealth Screening - Creating a Big Data

May 30, 2017 updated by: KK Women's and Children's Hospital

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Children with severe behavioral
  2. Droplet isloated cases as determined by protocol of hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute phase acoustic spectrum Analysis
Time Frame: Day 0-7
Acoustic classifiers
Day 0-7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery or Chronic phase acoustic spectrum analysis
Time Frame: Day 7-30
Acoustic classifiers
Day 7-30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hwan Ing Hee, MBBCH BAO, KK Women's and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Anticipated)

March 31, 2018

Study Completion (Anticipated)

March 31, 2018

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • KKWCH 2016/2416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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