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Improved Discrimination Of Central And Obstructive Apnoeas In Infants

Primary Purpose

Central And Obstructive Apnoeas In Infants

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Volusense paediatric monitoring device
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Central And Obstructive Apnoeas In Infants

Eligibility Criteria

36 Weeks - 12 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • Sheffield Children's NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Breathing test or sleep study

Arm Description

infants undertaking cardiorespiratory polysomnography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2015
Last Updated
January 15, 2020
Sponsor
Sheffield Children's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04234074
Brief Title
Improved Discrimination Of Central And Obstructive Apnoeas In Infants
Official Title
Improved Discrimination Of Central And Obstructive Apnoeas In Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 28, 2014 (Actual)
Primary Completion Date
March 3, 2017 (Actual)
Study Completion Date
March 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central And Obstructive Apnoeas In Infants

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing test or sleep study
Arm Type
Other
Arm Description
infants undertaking cardiorespiratory polysomnography
Intervention Type
Device
Intervention Name(s)
Volusense paediatric monitoring device
Other Intervention Name(s)
Volusense
Intervention Description
Comparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography.
Primary Outcome Measure Information:
Title
Whether comparable to gold standard - cardiorespiratory polysomnogram
Description
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
Time Frame
74 months
Secondary Outcome Measure Information:
Title
To find if Volusense detects central and obstructive apnoea
Description
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
Time Frame
74 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelechi Ugonna
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
State/Province
Sheffield (South Yorkshire District)
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Improved Discrimination Of Central And Obstructive Apnoeas In Infants

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