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Improved Discrimination Of Central And Obstructive Apnoeas In Infants

Improved Discrimination Of Central And Obstructive Apnoeas In Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04234074
Enrollment
30
Registered
2020-01-21
Start date
2014-02-28
Completion date
2017-03-03
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central And Obstructive Apnoeas In Infants

Brief 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 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.

Interventions

DEVICEVolusense paediatric monitoring device

Comparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography.

Sponsors

Sheffield Children's NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
36 Weeks to 12 Months
Healthy volunteers
No

Inclusion criteria

•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.

Exclusion criteria

•Chest wall deformity on injury that precludes the use of the Volusense paediatric device.

Design outcomes

Primary

MeasureTime frameDescription
Whether comparable to gold standard - cardiorespiratory polysomnogram74 monthsTo measure the number of central apnoeas, obstructive apnoeas and hyponeas recorded and measured through the night. The apnoea/hyponea index will then be calculated

Secondary

MeasureTime frameDescription
To find if Volusense detects central and obstructive apnoea74 monthsTo measure the number of central apnoeas, obstructive apnoeas and hyponeas recorded and measured through the night. The apnoea/hyponea index will then be calculated

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026