NCT04190953 Upper Airway's Pressure Drop Analyses After Mandibular Advancement and Maxillary Expansion
| NCT ID | NCT04190953 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2020-02-18 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2020-02-18 with a primary completion date of 2027-03-01.
⚠ 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
Breathing is a crucial function for everyone. Breathing impairment in children could lead to behavioral and cognitive problems at least. But what if orthodontic treatment could help those patients to breathe better, with less effort? This research proposal aims to find out if the increase in the upper airway volume seen in some research results can be related to a decrease in respiratory effort and an improvement in the breathing capacity of those patients. In other words, if a tube shape is changed or if a tube is enlarged, would the airflow passing inside the tube change in velocity? Or would there be more air? Therefore, investigating the pressure/airflow, volume/lumen relation and its possible changes after mandibular repositioning and maxillary expansion in children will lead to a better understanding of how orthodontics could potentially affect the upper airway. Previous studies have reported a link between mandibular advancement appliances and maxillary appliances to an increase in the upper airway volume. However, more studies are needed to evaluate the relationship between the changes in the upper airway volume and actual airflow and respiratory capability. The airway volume measurement is important to, preliminary, state if there is an increase in the upper airway after orthodontic treatment. However a change in shape, even with the same volume, can affect the pressure and airflow. In this sense, the pressure drop analysis will allow an answer to those questions
Eligibility Criteria
Inclusion Criteria: * children between the ages 8-14 years old (8-12 years old girls and 9-14 years old boys), presenting skeletal class II division 1 malocclusion with maxillary constriction Exclusion Criteria: * syndromic patients, previous ortho history, non-compliance, severe oral health issues (cavities, poor oral hygiene)
Contact & Investigator
Silvia G Capenakas, MSc
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT04190953 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 14 Years, studying Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04190953 currently recruiting?
Yes, NCT04190953 is actively recruiting participants. Contact the research team at manuel@ualberta.ca for enrollment information.
Where is the NCT04190953 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT04190953 clinical trial?
NCT04190953 is sponsored by University of Alberta. The principal investigator is Silvia G Capenakas, MSc at University of Alberta. The trial plans to enroll 90 participants.