Actively Recruiting
Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
Led by Oslo University Hospital · Updated on 2024-06-18
50
Participants Needed
2
Research Sites
573 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
U
University of Oslo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Laryngomalacia
- Stridor
- Breathing difficulties
You will not qualify if you...
- None
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Oslo University Hospital
Oslo, Norway, 0372
Actively Recruiting
2
Lovisenberg Diaconal Hospital
Oslo, Norway, 0456
Actively Recruiting
Research Team
H
Harriet Akre
CONTACT
B
Britt Øverland
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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