Improved Discrimination Of Central And Obstructive Apnoeas In Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-03-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Central And Obstructive Apnoeas In Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Breathing test or sleep study

infants undertaking cardiorespiratory polysomnography

Group Type OTHER

Volusense paediatric monitoring device

Intervention Type DEVICE

Comparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography.

Interventions

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Volusense paediatric monitoring device

Comparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography.

Intervention Type DEVICE

Other Intervention Names

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Volusense

Eligibility Criteria

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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.