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
N/A
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
This research investigates laryngomalacia, a common cause of noisy breathing (stridor) in children under 1 year old. The study aims to understand how sleep examinations can help determine which children might benefit from surgery and to follow their progress after 4-6 weeks and again after 1 year. It also compares children with laryngomalacia to healthy children by examining sleep quality and life impact using questionnaires. The study involves sleep tests using polygraphy or polysomnography with audio and video monitoring, as well as a device called Somnofy from VitalThings. Children will be monitored during sleep both at the hospital and at home. The researchers will use artificial intelligence and machine learning to analyze these sleep exams. There is a control group of healthy children under 1 year old who will also have their sleep and quality of life assessed over 1 year. Participants will have their breathing and sleep monitored, and quality of life will be evaluated with the ITQoL-SF47 questionnaire. Follow-up visits will occur at 4-6 weeks and 1 year to track changes. The main outcomes measured include the apnea-hypopnea index and quality of life in toddlers. The study is observational and aims to provide important information about breathing problems and treatment effects on young children and their families.
CONDITIONS
Brief 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...
- Children under 1 year of age
- Diagnosed with laryngomalacia
- Presence of stridor (noisy breathing)
- Breathing difficulties
You will not qualify if you...
- none
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo thorough anatomical examinations of the upper respiratory tract to identify causes of breathing difficulties and stridor.
Multiple visits over the year
Duration - Up to 1 year
Participants are followed up for up to 1 year to assess sleep quality and quality of life using sleep examinations and questionnaires.
Periodic visits during follow-up
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
B
Britt Øverland
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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