Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
Recruiting now
Conditions studied: Laryngomalacia, Sleep Apnea, Obstructive, Sleep Apnea, Ear, Nose and Throat Disorder, Pediatric Disorder, Surgery, Quality of Life
In brief
Laryngomalacia is the most frequent cause of stridor in children under 1 year. The airway obstruction generates turbulent airway flow and creates the characteristic high-frequency stridor sound. In addition, the airway obstruction can cause apnea, a following drop in oxygen saturation and sleep disturbances. The symptoms of laryngomalacia are often worsened by activity, feeding, crying and lying flat on the back. The diagnosis is made with flexible laryngoscopy when the child is awake. The children are most often treated with expectation, information and guidance, observation with help with feeding and reflux treatment. Up to 20% of patients have a severe degree of laryngomalacia with apneas, which is an indication for surgical treatment. The investigators want to examine whether sleep examinations can help us deciding which child benefit from surgery, and follow-up the child again after 4-6 weeks and 1 year. The sleep examinations are carried out with polygraphy and/or polysomnography with simultaneous audio records and video monitoring and with Somnofy from VitalThings. The investigators want to use artificial intelligence and machine learning when analyzing the sleep examinations. The investigators also want to have a control group examining the sleep and breathing during night at home. In both groups the investigators want to examine the quality of life with the questionnaire ITQoL-SF47.
Key facts
- Study ID
- NCT06464757
- Run by
- Oslo University Hospital
- People needed
- 50
- Starts
- 2024-01-01
- Expected to finish
- 2034-12-31
- Last updated by the study team
- 2024-06-18
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- laryngomalacia
- stridor
- breathing difficulties
You may not qualify if…
- none
Where it is running
- Oslo University Hospital — Oslo, Norway (enrolling)
- Lovisenberg Diaconal Hospital — Oslo, Norway (enrolling)
Full record on ClinicalTrials.gov
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