Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-52
SponsorOslo University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

laryngomalacia

stridor

breathing difficulties

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

50 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Oslo University Hospital

Lead sponsor

University of Oslo

Collaborator

Lovisenberg Diakonale Hospital

Collaborator