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

NCT06464757 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-06-18

No results posted yet for this study

Summary

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

  • Laryngomalacia
  • Sleep Apnea, Obstructive
  • Sleep Apnea
  • Ear, Nose and Throat Disorder
  • Pediatric Disorder
  • Surgery
  • Quality of Life

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Lovisenberg Diakonale Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Eligibility

Min Age
1 Week
Max Age
52 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2034-12-31
Completion
2034-12-31

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06464757 on ClinicalTrials.gov