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Improved Discrimination Of Central And Obstructive Apnoeas In Infants

NHS Foundation Trust logo

NHS Foundation Trust

Status

Completed

Conditions

Central And Obstructive Apnoeas In Infants

Treatments

Device: Volusense paediatric monitoring device

Study type

Interventional

Funder types

Other

Identifiers

NCT04234074
SCH/13/023

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

36 weeks to 12 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Breathing test or sleep study
Other group
Description:
infants undertaking cardiorespiratory polysomnography
Treatment:
Device: Volusense paediatric monitoring device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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