LaryngomalaciaNCT06464757
Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
An observational study of Laryngomalacia and Sleep Apnea, Obstructive, run by Oslo University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 week to 52 weeksHealthy volunteers can take part
- Conditions the study is for
- Laryngomalacia, Sleep Apnea, Obstructive, Sleep Apnea
- How many people
- 50 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Jan 2024to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 52 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with laryngomalacia, stridor and/or breathing difficulties.
Who may be able to join
- laryngomalacia
- stridor
- breathing difficulties
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0372
Harriet Akre, +4723070000, harriet.akre@medisin.uio.no
- Recruiting
Lovisenberg Diaconal Hospital
Oslo, 0456
Britt Øverland, +4723225000
About this study
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.
Read the detailed description
Breathing difficulties in young children are a common cause of contact in the health care system, and are often related to harmless infection-triggered conditions in the upper and lower respiratory tract. In the vast majority of the cases, the condition is self-limiting and the child can be treated in primary care. In more serious or long-term cases, the child is referred to the specialist health care, most often to pediatricians, where the focus is naturally directed to pulmonary medical causes such as asthma, allergies and infections, as these make up the majority of breathing difficulties in children. Less common and less well-known are breathing difficulties in young children caused by airway obstructions in the upper airways, which might cause a characteristic respiratory distress called stridor. Stridor occurs as a result of turbulent airflow through a relatively narrower part of the upper airways, such as the larynx and trachea, and produces a high-frequency whistling sound during inspiration. Causes of stridor can be congenital or acquired, and stridor can often be confused with asthma. It is appropriate to refer to an ENT doctor for a thorough anatomical examination of the upper respiratory tract in these affected children to identify the cause of stridor and to be able to provide the correct treatment.
Laryngomalacia is the most frequent cause of stridor in children under 1 year of age, and is a congenital condition where the tissue at the top of the larynx collapses over the airway opening to the larynx and therefore creates an upper airway obstruction during inspiration. In severe cases, laryngomalacia can be curatively treated with surgery.
For long time the ENT departments and pediatric departments at regional hospitals in Norway have been responsible for the treatment of children under 1 year of age with laryngomalacia. However, experience in children under 1 year with laryngomalacia is limited, and there is a lack of systematic mapping and follow-up of these children. In Health South-East in Norway, with approximately 3.1 million inhabitants, children with a severe degree of stridor will be referred to the ENT department and/or the pediatric department at Oslo University Hospital. In addition, Oslo University Hospital also receives children with stridor from other health regions in Norway. Therefore, the patient base is well suited for a systematic mapping and follow-up. In this research project, the investigators want to carry out a mapping and follow-up of children with laryngomalacia, investigate how affected these children are by their breathing difficulties and the impact it has on sleep and quality of life on the child and the family. The investigators also want to investigate whether the treatment improves these variables.
In addition, the investigators want to recruit a control group of healthy children under 1 year of age to examine sleep and mapping the quality of life of the child and family. These children will be recruited from health centers, and the investigators want to follow them for up to 1 year.
In both groups the investigators want to use artificial intelligence and machine learning when analyzing the sleep examinations.
- Conditions
- Laryngomalacia, Sleep Apnea, Obstructive, Sleep Apnea, Ear, Nose and Throat Disorder, Pediatric Disorder, Surgery
- Medical subject headings
- Laryngomalacia, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with laryngomalacia | Not described | |
| Healthy children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea-index
Apnea-hypopnea-index
Measured: 10 years
Quality of life in toddlers
Quality of life by using the Infant and Toddler Quality of Life Questionnaire (ITQOL-SF47)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngomalaciaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Lovisenberg Diakonale Hospital
- Responsible party
- Principal investigator, Harriet Akre, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464757
- Sponsor's protocol ID
- 646948
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
- ClinicalTrials.gov ID
- NCT06464757
- Acronym / sponsor ID
- 646948
- Conditions
- Laryngomalacia, Sleep Apnea, Obstructive, Sleep Apnea, Ear, Nose and Throat Disorder, Pediatric Disorder, Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Lovisenberg Diakonale Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breathing difficulties in young children are a common cause of contact in the health care system, and are often related to harmless infection-triggered conditions in the upper and lower respiratory tract. In the vast majority of the cases, the condition is self-limiting and the child can be treated in primary care. In more serious or long-term cases, the child is referred to the specialist health care, most often to pediatricians, where the focus is naturally directed to pulmonary medical causes such as asthma, allergies and infections, as these make up the majority of breathing difficulties in children. Less common and less well-known are breathing difficulties in young children caused by airway obstructions in the upper airways, which might cause a characteristic respiratory distress called stridor. Stridor occurs as a result of turbulent airflow through a relatively narrower part of the upper airways, such as the larynx and trachea, and produces a high-frequency whistling sound during inspiration. Causes of stridor can be congenital or acquired, and stridor can often be confused with asthma. It is appropriate to refer to an ENT doctor for a thorough anatomical examination of the upper respiratory tract in these affected children to identify the cause of stridor and to be able to provide the correct treatment.
Laryngomalacia is the most frequent cause of stridor in children under 1 year of age, and is a congenital condition where the tissue at the top of the larynx collapses over the airway opening to the larynx and therefore creates an upper airway obstruction during inspiration. In severe cases, laryngomalacia can be curatively treated with surgery.
For long time the ENT departments and pediatric departments at regional hospitals in Norway have been responsible for the treatment of children under 1 year of age with laryngomalacia. However, experience in children under 1 year with laryngomalacia is limited, and there is a lack of systematic mapping and follow-up of these children. In Health South-East in Norway, with approximately 3.1 million inhabitants, children with a severe degree of stridor will be referred to the ENT department and/or the pediatric department at Oslo University Hospital. In addition, Oslo University Hospital also receives children with stridor from other health regions in Norway. Therefore, the patient base is well suited for a systematic mapping and follow-up. In this research project, the investigators want to carry out a mapping and follow-up of children with laryngomalacia, investigate how affected these children are by their breathing difficulties and the impact it has on sleep and quality of life on the child and the family. The investigators also want to investigate whether the treatment improves these variables.
In addition, the investigators want to recruit a control group of healthy children under 1 year of age to examine sleep and mapping the quality of life of the child and family. These children will be recruited from health centers, and the investigators want to follow them for up to 1 year.
In both groups the investigators want to use artificial intelligence and machine learning when analyzing the sleep examinations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with laryngomalacia | – | – |
| Healthy children | – | – |
Who may qualify
- Ages
- 1 week to 52 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with laryngomalacia, stridor and/or breathing difficulties.
Key inclusion criteria (3 listed)
- laryngomalacia
- stridor
- breathing difficulties
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apnea-hypopnea-index
Time frame: 10 years
Apnea-hypopnea-index
Quality of life in toddlers
Time frame: 10 years
Quality of life by using the Infant and Toddler Quality of Life Questionnaire (ITQOL-SF47)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Related trials for Laryngomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngomalacia and Sleep Apnea, Obstructive, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harriet Akre (+4723070000, harriet.akre@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea-index (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.