Sleep Disordered Breathing in Infants with Laryngomalacia
Research type
Research Study
Full title
A Pilot Study to Determine the Prevalence of Sleep Disordered Breathing in Infants with Laryngomalacia
IRAS ID
141095
Contact name
Hazel Evans
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Laryngomalacia is a common condition of infancy characterised by floppiness of the upper airway, leading to variable degrees of airway obstruction during inspiration. It is the most common cause of stridor (noisy breathing during inspiration) in infants and usually presents within the first two weeks of life. Diagnosis can be confirmed by laryngoscopy, which allows direct visualisation of the upper airway. Severe laryngomalacia may be complicated by failure to thrive and hypoxaemia (low oxygen saturations).
Symptoms of laryngomalacia tend to be worse during periods of activity and are less obvious during sleep. However, rapid eye movement (REM) sleep is associated with reduced upper airway tone and is therefore a time of increased susceptibility to airway obstruction. The degree of airways obstruction in children with laryngomalacia who are otherwise thriving has not yet been evaluated despite increasing evidence that interruptions in breathing during sleep (obstructive sleep apnoea) may have adverse effects on neurodevelopment.
In this study, children under the age of 1 year with nasendoscopically confirmed laryngomalacia will be recruited from ENT clinics and admitted for overnight pulse oximetry and respiratory polygraphy. Data will collected from patients' medical records on growth and gastro-oesophageal reflux disease and parents will be asked to complete a paediatric sleep questionnaire and sleep log. Healthy age matched controls (without stridor and with no history of cardiac or respiratory disease) will be recruited from general surgical clinics and the paediatic medical wards. They will undergo the same investigations as those with laryngomalacia. The prevalence of sleep disordered breathing in the two groups will be compared. Study participation will be entirely voluntary and families will be free to withdraw at any point.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/1232
Date of REC Opinion
8 Dec 2014
REC opinion
Further Information Favourable Opinion