BronchiolitisWheezSmartNCT02897960
Wheezing Diagnosis Using a Smartphone
An observational study of Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute bronchiolitis. One third of these infants will develop recurrent episodes, leading to the diagnosis of infant asthma. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Bronchiolitis
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Jun 2017
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Infant selected in the emergency department: respiratory complaint
Who may be able to join
- infant 1 to 24 months old
- respiratory complaint in the emergency room
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wheezing Diagnosis Using a Smartphone in Infants Referred for Bronchiolitis
Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute bronchiolitis. One third of these infants will develop recurrent episodes, leading to the diagnosis of infant asthma. Nowadays, no available treatment shortens the course of bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our hypothesis is that the diagnosis of wheezing during bronchiolitis (~60% of infants) will help to select infants who will benefit from anti-asthma therapy. In this setting the diagnosis of wheezing is crucial, and an objective tool for recognition of wheezing is of clinical value. The investigators developed a wheezing recognition algorithm from recorded respiratory sounds with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016). The objectives of the present cross sectional, observational study are 1/ to further validate our approach in a larger sample of infants (1 to 24 months) admitted to hospital for a respiratory complaint during the period of viral bronchiolitis, and 2/ to use gold standard diagnosis of wheezing by respiratory sound recording (Littmann) and subsequent analysis by two experienced pediatricians.
Read the detailed description
Infants (1 to 24 months old) are recruited in two emergency departments (Robert Debré; Antoine Béclère hospitals of Assistance publique - Hôpitaux de Paris) based on a respiratory complaint. Six characteristics are recorded (age, sex, SpO2, presence or absence of wheezing, other respiratory sound, initial diagnosis). Two recordings of respiratory sounds are obtained almost simultaneously: one with a Smartphone at the mouth (5 cm) and one with an electronic stetoscope (Littmann). Two expert pediatricians listen the recordings giving thee groups: with wheezing (agreement), without wheezing (agreement) and non agreement diagnosis. The recordings made with the Smartphone are subjected to the wheezing recognition algorithm as previously described. The sensitivity, specificity, PPV, NPP are then evaluated. The algorithm will further be improved if necessary using the true negative and true positive recordings (those with expert agreement).
- Conditions
- Bronchiolitis
- Keywords
- wheezing, bronchiolitis, respiratory sound algorithm
- Medical subject headings
- Bronchiolitis, Respiratory Sounds
What is being measured
The primary outcome is the main question the study is designed to answer.
positive and negative predictive values of the algorithm for wheezing diagnosis
Measured: 8 months
Secondary outcomes (1)
sensibility and specificity of the algorithm in subgroups
The sensibility and specificity of the algorithm will be assessed for recordings with other respiratory sounds (crackles for instance) The agreement (kappa value) between the emergency room sound diagnosis and both the expert and algorithm diagnosis (diagnostic ability of the physician in the emergency room)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017
- Study completionJun 2017
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 BronchiolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897960
- Sponsor's protocol ID
- ID RCB : 2015-A01499-40
- Acronym
- WheezSmart
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2016
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bokov P, Mahut B, Flaud P, Delclaux C. Wheezing recognition algorithm using recordings of respiratory sounds at the mouth in a pediatric population. Comput Biol Med. 2016 Mar 1;70:40-50. doi: 10.1016/j.compbiomed.2016.01.002. Epub 2016 Jan 8.
PubMed 26802543
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheezing Diagnosis Using a Smartphone in Infants Referred for Bronchiolitis
- ClinicalTrials.gov ID
- NCT02897960
- Acronym / sponsor ID
- WheezSmart / ID RCB : 2015-A01499-40
- Conditions
- Bronchiolitis
- Keywords
- wheezing, bronchiolitis, respiratory sound algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute bronchiolitis. One third of these infants will develop recurrent episodes, leading to the diagnosis of infant asthma. Nowadays, no available treatment shortens the course of bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our hypothesis is that the diagnosis of wheezing during bronchiolitis (~60% of infants) will help to select infants who will benefit from anti-asthma therapy. In this setting the diagnosis of wheezing is crucial, and an objective tool for recognition of wheezing is of clinical value. The investigators developed a wheezing recognition algorithm from recorded respiratory sounds with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016). The objectives of the present cross sectional, observational study are 1/ to further validate our approach in a larger sample of infants (1 to 24 months) admitted to hospital for a respiratory complaint during the period of viral bronchiolitis, and 2/ to use gold standard diagnosis of wheezing by respiratory sound recording (Littmann) and subsequent analysis by two experienced pediatricians.
Detailed description
Infants (1 to 24 months old) are recruited in two emergency departments (Robert Debré; Antoine Béclère hospitals of Assistance publique - Hôpitaux de Paris) based on a respiratory complaint. Six characteristics are recorded (age, sex, SpO2, presence or absence of wheezing, other respiratory sound, initial diagnosis). Two recordings of respiratory sounds are obtained almost simultaneously: one with a Smartphone at the mouth (5 cm) and one with an electronic stetoscope (Littmann). Two expert pediatricians listen the recordings giving thee groups: with wheezing (agreement), without wheezing (agreement) and non agreement diagnosis. The recordings made with the Smartphone are subjected to the wheezing recognition algorithm as previously described. The sensitivity, specificity, PPV, NPP are then evaluated. The algorithm will further be improved if necessary using the true negative and true positive recordings (those with expert agreement).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infant selected in the emergency department: respiratory complaint
Key inclusion criteria (2 listed)
- infant 1 to 24 months old
- respiratory complaint in the emergency room
Key exclusion criteria (0 listed)
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
positive and negative predictive values of the algorithm for wheezing diagnosis
Time frame: 8 months
1 secondary outcome
sensibility and specificity of the algorithm in subgroups
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Results publication: PubMed 26802543Bokov P, Mahut B, Flaud P, Delclaux C. Wheezing recognition algorithm using recordings of respiratory sounds at the mouth in a pediatric population. Comput Biol Med. 2016 Mar 1;70:40-50. doi: 10.1016/j.compbiomed.2016.01.002. Epub 2016 Jan 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 6 Feb 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
positive and negative predictive values of the algorithm for wheezing diagnosis (time frame: 8 months). 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 NCT02897960, 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 6 Feb 2023.