Central And Obstructive Apnoeas In InfantsNCT04234074
Improved Discrimination Of Central And Obstructive Apnoeas In Infants
A study testing Volusense paediatric monitoring device in people with Central And Obstructive Apnoeas In Infants, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Referral of infants to the respiratory sleep disorders breathing team with apnoeas [pauses in their breathing] and apparent life-threatening episodes are frequent. While the majority of such episodes do not have a significant underlying problem a potentially life threatening condition accounts for a significant… Read more about this study
- Who is it for?
- Ages 36 weeks to 12 months
- Conditions the study is for
- Central And Obstructive Apnoeas In Infants
- What is being tested?
- Volusense paediatric monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2014to 3 Mar 2017
- Phase
- Interventional
- 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 36 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- •Infants between 36 weeks post conception and one year old referred to the respiratory and sleep team for central or obstructive apnoea or apparent life threatening events.
Who cannot join
- •Chest wall deformity on injury that precludes the use of the Volusense paediatric device.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Referral of infants to the respiratory sleep disorders breathing team with apnoeas [pauses in their breathing] and apparent life-threatening episodes are frequent. While the majority of such episodes do not have a significant underlying problem a potentially life threatening condition accounts for a significant proportion of cases.
In order to fully assess an infant, a full-scale overnight polysomnography study would be required. Unfortunately due to the complexity of such studies and because the equipment is generally fully booked for many weeks ahead it is extremely difficult to arrange timely assessment. Hence, currently, we are largely reliant on simple screening with pulse oximetry (measuring oxygen levels in the blood with a simple probe). This is able to identify potentially significant problems, but it is does not help to determine whether this is because the baby simply stops breathing for a period due to disturbance of its control of breathing, or whether it is experiencing obstructive episodes, for which there are a number of causes. This new equipment to be assessed would potentially provide a simple, robust means of undertaking definitive studies simply and effectively on the medical wards with assessment of chest and abdominal wall movement being linked to pulse oximetry.
This is likely to provide a substantial and significant improvement on our current practice. The benefits will be that, for those with no significant underlying problems, we will be able to provide much greater reassurance for the parents, which is clearly very valuable, while in those with a problem we will be able to distinguish those with central or obstructive apnoea with a degree of certainty that will greatly streamline further assessments and treatment.
- Being tested
- Volusense paediatric monitoring device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volusense paediatric monitoring deviceDevice
Also called Volusense
Comparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| Breathing test or sleep study | Other | infants undertaking cardiorespiratory polysomnography Receives: Device: Volusense paediatric monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether comparable to gold standard - cardiorespiratory polysomnogram
To measure the number of central apnoeas, obstructive apnoeas and hyponeas recorded and measured through the night. The apnoea/hyponea index will then be calculated
Measured: 74 months
Secondary outcomes (1)
To find if Volusense detects central and obstructive apnoea
To measure the number of central apnoeas, obstructive apnoeas and hyponeas recorded and measured through the night. The apnoea/hyponea index will then be calculated
Measured: 74 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start28 Feb 2014
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central And Obstructive Apnoeas In InfantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelechi Ugonna, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234074
- Sponsor's protocol ID
- SCH/13/023
- Status last verified
- Jan 2020
- First submitted
- 4 Dec 2015
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Discrimination Of Central And Obstructive Apnoeas In Infants
- ClinicalTrials.gov ID
- NCT04234074
- Acronym / sponsor ID
- SCH/13/023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 28 Feb 2014 (actual)
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 21 Jan 2020 (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.
Referral of infants to the respiratory sleep disorders breathing team with apnoeas [pauses in their breathing] and apparent life-threatening episodes are frequent. While the majority of such episodes do not have a significant underlying problem a potentially life threatening condition accounts for a significant proportion of cases.
In order to fully assess an infant, a full-scale overnight polysomnography study would be required. Unfortunately due to the complexity of such studies and because the equipment is generally fully booked for many weeks ahead it is extremely difficult to arrange timely assessment. Hence, currently, we are largely reliant on simple screening with pulse oximetry (measuring oxygen levels in the blood with a simple probe). This is able to identify potentially significant problems, but it is does not help to determine whether this is because the baby simply stops breathing for a period due to disturbance of its control of breathing, or whether it is experiencing obstructive episodes, for which there are a number of causes. This new equipment to be assessed would potentially provide a simple, robust means of undertaking definitive studies simply and effectively on the medical wards with assessment of chest and abdominal wall movement being linked to pulse oximetry.
This is likely to provide a substantial and significant improvement on our current practice. The benefits will be that, for those with no significant underlying problems, we will be able to provide much greater reassurance for the parents, which is clearly very valuable, while in those with a problem we will be able to distinguish those with central or obstructive apnoea with a degree of certainty that will greatly streamline further assessments and treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing test or sleep study | Other | Device: Volusense paediatric monitoring deviceinfants undertaking cardiorespiratory polysomnography |
Who may qualify
- Ages
- 36 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- •Infants between 36 weeks post conception and one year old referred to the respiratory and sleep team for central or obstructive apnoea or apparent life threatening events.
Key exclusion criteria (1 listed)
- •Chest wall deformity on injury that precludes the use of the Volusense paediatric device.
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 |
|---|---|---|
| Volusense paediatric monitoring deviceAlso: VolusenseComparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography. | Device | Breathing test or sleep study |
Primary outcome
Whether comparable to gold standard - cardiorespiratory polysomnogram
Time frame: 74 months
To measure the number of central apnoeas, obstructive apnoeas and hyponeas recorded and measured through the night. The apnoea/hyponea index will then be calculated
1 secondary outcome
To find if Volusense detects central and obstructive apnoea
Time frame: 74 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 21 Jan 2020.
Related trials for Central And Obstructive Apnoeas In Infants
Not yet recruitingObservational study
Automated Apnoea Detection in Preterms on Non-invasive Ventilation
Apnoea, Prematurity
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.
Kelechi Ugonna principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volusense paediatric monitoring device in people with Central And Obstructive Apnoeas In Infants, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 21 Jan 2020. 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 Kingdom. 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?
Whether comparable to gold standard - cardiorespiratory polysomnogram (time frame: 74 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2020.