Improved Discrimination Of Central And Obstructive Apnoeas In Infants

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 Overview

• Status: Completed
• Conditions: Central And Obstructive Apnoeas In Infants
• Intervention / Treatment: Device: Volusense paediatric monitoring device

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield (South Yorkshire District)
    • Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH
      • Sheffield Children's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Breathing test or sleep study; infants undertaking cardiorespiratory polysomnography	Device: Volusense paediatric monitoring device; Comparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography.; Other Names: Volusense

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	74 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	74 months

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust
• Investigators: Principal Investigator: Kelechi Ugonna, Investigator

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2014
• Primary Completion (ACTUAL): March 3, 2017
• Study Completion (ACTUAL): March 3, 2017

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (ACTUAL): January 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: SCH/13/023