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Behavioural Intervention

Orthodontic Treatment for Sleep Apnea

N/A

Recruiting

Led By Silvia G Capenakas, MSc

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial aims to find out if orthodontic treatment can help children with breathing impairments by increasing the upper airway volume.

Who is the study for?

This trial is for children aged 8-14 with a specific dental misalignment (skeletal class II division 1 malocclusion) and narrowed upper jaw. It's not open to those who've had previous orthodontic treatment, aren't likely to follow the study rules, have serious dental problems like cavities or bad hygiene, or have genetic syndromes.Check my eligibility

What is being tested?

The study tests whether two orthodontic treatments can improve breathing in kids by changing the shape and size of their airways. One group will first use a Hyrax device then switch to a Twin block brace; another group does this in reverse order.See study design

What are the potential side effects?

Orthodontic devices like Hyrax and Twin block may cause discomfort, pain, speech difficulties, changes in chewing function, and possible irritation inside the mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is 8-14 years old with a specific type of jaw misalignment and a narrow upper jaw.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Airflow

Secondary outcome measures

Dental changes

Skeletal changes

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Twin Block then HyraxExperimental Treatment1 Intervention

Patients will undergo mandibular advancement prior to maxillary expansion using Twin block prior to Hyrax

Group II: Hyrax then Twin blockExperimental Treatment1 Intervention

Patients will undergo maxillary expansion prior to mandibular advancement using Hyrax prior to Twin block

Group III: ControlActive Control1 Intervention

Patients will wait 1,5 years before the start of treatment

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,868 Total Patients Enrolled

Silvia G Capenakas, MScPrincipal InvestigatorUniversity of Alberta

Media Library

Hyrax then Twin block (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04190953 — N/A

Sleep Apnea Research Study Groups: Hyrax then Twin block, Control, Twin Block then Hyrax

Sleep Apnea Clinical Trial 2023: Hyrax then Twin block Highlights & Side Effects. Trial Name: NCT04190953 — N/A

Hyrax then Twin block (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04190953 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research endeavor open to me?

"The requirements to qualify for this clinical trial include nasal airway obstruction and being aged between 8-14. Currently, approximately 90 participants are sought after by the medical team in charge of this study."

Answered by AI

Does this investigation take into consideration individuals who are more than 45 years of age?

"The present investigation is enrolling patients aged between 8 and 14 years."

Answered by AI

Is enrollment currently open for the trial participants?

"Affirmative. Per the information hosted on clinicaltrials.gov, this medical trial is actively seeking participants since its initial posting date of February 18th 2020. Approximately 90 individuals are needed from a single centre to complete enrollment for the study."

Answered by AI

How many individuals are currently taking part in this clinical trial?

"This is accurate. According to clinicaltrials.gov, this medical investigation commenced on February 18th 2020 and continues to accept enrollees as of June 6th 2022. The study requires 90 individuals from a single location for completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Upper Airway's Pressure Drop Analyses After Mandibular Advancement and Maxillary Expansion

2020. "Upper Airway's Pressure Drop Analyses After Mandibular Advancement and Maxillary Expansion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04190953.