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

NCT06464757 | Recruiting

• 1 other identifier: 646948
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Apnea-hypopnea-index

  Apnea-hypopnea-index

  10 years

• Quality of life in toddlers

  Quality of life by using the Infant and Toddler Quality of Life Questionnaire (ITQOL-SF47)

  10 years

Study Arms (2)

Children with laryngomalacia

Healthy children

Eligibility Criteria

• Age: 1 Week - 52 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with laryngomalacia, stridor and/or breathing difficulties.

You may qualify if:

• laryngomalacia
• stridor
• breathing difficulties

You may not qualify if:

• \- none

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Lovisenberg Diakonale Hospital: collaborator

Study Sites (2)

Oslo University Hospital

Oslo, 0372, Norway

RECRUITING

Lovisenberg Diaconal Hospital

Oslo, 0456, Norway

RECRUITING

MeSH Terms

Conditions

Laryngomalacia; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Harriet Akre

CONTACT

+4723070000; harriet.akre@medisin.uio.no

Britt Øverland

CONTACT

+4723225000; brov@lds.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 18, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

NO (2)