NCT06464757 Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
| NCT ID | NCT06464757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Laryngomalacia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2034-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-01-01 with a primary completion date of 2034-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * laryngomalacia * stridor * breathing difficulties Exclusion Criteria: \- none
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06464757 clinical trial?
This trial is open to participants of all sexes, aged 1 Week or older, up to 52 Weeks, studying Laryngomalacia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06464757 currently recruiting?
Yes, NCT06464757 is actively recruiting participants. Contact the research team at harriet.akre@medisin.uio.no for enrollment information.
Where is the NCT06464757 trial being conducted?
This trial is being conducted at Oslo, Norway, Oslo, Norway.
Who is sponsoring the NCT06464757 clinical trial?
NCT06464757 is sponsored by Oslo University Hospital. The trial plans to enroll 50 participants.