Actively Recruiting

Age: 1Week - 52Weeks
All Genders
Healthy Volunteers
NCT06464757

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

Age: 1Week - 52Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Laryngomalacia
  • Stridor
  • Breathing difficulties
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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