Pediatric Obstructive Sleep ApneaNCT03821831
Treating Children With Obstructive Sleep Apnea After Surgery Failure
An observational study of Pediatric Obstructive Sleep Apnea and Pediatric Obesity, run by University of Alberta at 1 site in Canada.
Trial summary
The aim of this study is to evaluate the potential improvement of sleep quality in children who have residual obstructive sleep apnea, using either an orthodontic intervention or continuous positive airway pressure (CPAP), versus no treatment. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Pediatric Obstructive Sleep Apnea, Pediatric Obesity
- What is being tested?
- Continuous Positive Airway Pressure and Orthodontic intervention
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 3 Dec 2021to 8 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children from 6 to16 years old, from both sexes in Alberta, Canada, diagnosed with (a) residual OSA (post-T\&A) or (b) diagnosed with OSA but for whom T\&A is not a treatment option.
Who may be able to join
- Patients diagnosed with obstructive sleep apnea by polysomnography who presented with a failure in treatment with surgical removal of the tonsils and adenoid tissue --adenotonsillectomy (T\&A).
- Patients diagnosed with obstructive sleep apnea but for whom T\&A was not an option following assessment by Otolaryngology.
Who cannot join
- Autism spectrum
- Down syndrome
- Pulmonary hypertension
- Cystic fibrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap
The aim of this study is to evaluate the potential improvement of sleep quality in children who have residual obstructive sleep apnea, using either an orthodontic intervention or continuous positive airway pressure (CPAP), versus no treatment.
Read the detailed description
Consenting patients and their parents will choose one of three options (within the context of medical/craniofacial appropriateness): CPAP, orthodontic intervention, or to remain untreated (control). It would be ideal if each patient was randomly assigned to one of three groups. However, in our study, random allocation is not an option as the established clinical pathways for treatment, financial resources, and physiological presentation of the patient determines the appropriate intervention. In each group, the effectiveness of the intervention will be analyzed through the evaluation of sleep parameters, medical history, questionnaire responses, craniofacial characteristics, diet, and metabolomic markers, each at baseline and at 12 months.
- Being tested
- Continuous Positive Airway Pressure, Orthodontic intervention
- Keywords
- Obstructive sleep apnea, Children, Orthodontic intervention, Nutrition, Metabolomic markers
- Medical subject headings
- Pediatric Obesity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
CPAP machine
Orthodontic interventionDevice
Mandibular advancement or Rapid maxillary expansion devices
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | This group consists of consenting patients and their parents who choose Continuous Positive Airway Pressure (CPAP). The CPAP is a type of therapy that applies mild air pressure to a person's upper airway to keep their airway open so that they can breathe normally while they sleep. Receives: Device: Continuous Positive Airway Pressure | |
| Orthodontic Intervention | This group consists of consenting patients and their parents who choose orthodontic intervention will be seen by participating orthodontists who will determine types of orthodontic intervention; mandibular advancement devices or rapid maxillary expansion devices, or Class III mid face advancement with skeletal anchored headgear. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study. Receives: Device: Orthodontic intervention | |
| Control | This group consists of consenting patients and their parents who choose to remain untreated. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of change in OSA severity
Change from baseline Apnea-Hypopnea Index (OSA severity index) measurement by polysomnography at 12 months
Measured: baseline and 12 months
Change from baseline total score Pediatric Sleep Questionnaire (PSQ) at 12 months
PSQ consists of total 22 questions with choices of answer; Yes or No. Yes answer will be coded as 1 and No answer coded as 0. Sum of 22 questions will be compared.
Measured: baseline and 12 months
Secondary outcomes (1)
Change from baseline body mass index (BMI) at 12 months
Height (m) and weight (kg) will be measured to calculate BMI (kg/m^2).
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start3 Dec 2021
- Primary completion8 May 2023
- Study completion8 May 2023
Why it stopped: COVID hindered enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
- Investigators
- Giseon Heo, Principal investigator, Dentistry, University of AlbertaRochelle Young, Study chair, Pediatric Respiratory Medicine, University of Alberta HospitalPaul Major, Study director, Dentistry, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821831
- Sponsor's protocol ID
- GHeo
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2019
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fagundes NCF, Perez-Garcia A, Graf D, Flores-Mir C, Heo G. Orthodontic interventions as a management option for children with residual obstructive sleep apnea: a cohort study protocol. BMJ Open. 2022 Jun 15;12(6):e061651. doi: 10.1136/bmjopen-2022-061651.
PubMed 35705345
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Pediatric Obstructive Sleep Apnea: Closing the Treatment Gap
- ClinicalTrials.gov ID
- NCT03821831
- Acronym / sponsor ID
- GHeo
- Keywords
- Obstructive sleep apnea, Children, Orthodontic intervention, Nutrition, Metabolomic markers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID hindered enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 30 Jan 2019 (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.
The aim of this study is to evaluate the potential improvement of sleep quality in children who have residual obstructive sleep apnea, using either an orthodontic intervention or continuous positive airway pressure (CPAP), versus no treatment.
Detailed description
Consenting patients and their parents will choose one of three options (within the context of medical/craniofacial appropriateness): CPAP, orthodontic intervention, or to remain untreated (control). It would be ideal if each patient was randomly assigned to one of three groups. However, in our study, random allocation is not an option as the established clinical pathways for treatment, financial resources, and physiological presentation of the patient determines the appropriate intervention. In each group, the effectiveness of the intervention will be analyzed through the evaluation of sleep parameters, medical history, questionnaire responses, craniofacial characteristics, diet, and metabolomic markers, each at baseline and at 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | – | Device: Continuous Positive Airway PressureThis group consists of consenting patients and their parents who choose Continuous Positive Airway Pressure (CPAP). The CPAP is a type of therapy that applies mild air pressure to a person's upper airway to keep their airway open so that they can breathe normally while they sleep. |
| Orthodontic Intervention | – | Device: Orthodontic interventionThis group consists of consenting patients and their parents who choose orthodontic intervention will be seen by participating orthodontists who will determine types of orthodontic intervention; mandibular advancement devices or rapid maxillary expansion devices, or Class III mid face advancement with skeletal anchored headgear. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study. |
| Control | – | –This group consists of consenting patients and their parents who choose to remain untreated. In this group, the patients will also receive a biometric shirt to use once every two weeks, to monitor their sleep during the study. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children from 6 to16 years old, from both sexes in Alberta, Canada, diagnosed with (a) residual OSA (post-T\&A) or (b) diagnosed with OSA but for whom T\&A is not a treatment option.
Key inclusion criteria (2 listed)
- Patients diagnosed with obstructive sleep apnea by polysomnography who presented with a failure in treatment with surgical removal of the tonsils and adenoid tissue --adenotonsillectomy (T\&A).
- Patients diagnosed with obstructive sleep apnea but for whom T\&A was not an option following assessment by Otolaryngology.
Key exclusion criteria (4 listed)
- Autism spectrum
- Down syndrome
- Pulmonary hypertension
- Cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureCPAP machine | Device | Continuous Positive Airway Pressure |
| Orthodontic interventionMandibular advancement or Rapid maxillary expansion devices | Device | Orthodontic Intervention |
Primary outcome
Measure of change in OSA severity
Time frame: baseline and 12 months
Change from baseline Apnea-Hypopnea Index (OSA severity index) measurement by polysomnography at 12 months
Change from baseline total score Pediatric Sleep Questionnaire (PSQ) at 12 months
Time frame: baseline and 12 months
PSQ consists of total 22 questions with choices of answer; Yes or No. Yes answer will be coded as 1 and No answer coded as 0. Sum of 22 questions will be compared.
1 secondary outcome
Change from baseline body mass index (BMI) at 12 months
Time frame: baseline and 12 months
Results and safety
The study was stopped early (reason given: COVID hindered enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 35705345Fagundes NCF, Perez-Garcia A, Graf D, Flores-Mir C, Heo G. Orthodontic interventions as a management option for children with residual obstructive sleep apnea: a cohort study protocol. BMJ Open. 2022 Jun 15;12(6):e061651. doi: 10.1136/bmjopen-2022-061651.
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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. This study is not recruiting at the moment.
Giseon Heo principal investigator
Dentistry, University of Alberta
Rochelle Young study chair
Pediatric Respiratory Medicine, University of Alberta Hospital
Paul Major study director
Dentistry, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obstructive Sleep Apnea and Pediatric Obesity, run by University of Alberta at 1 site in Canada.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: COVID hindered enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of change in OSA severity (time frame: baseline and 12 months). 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?
On the ClinicalTrials.gov record for NCT03821831, which also lists 1 linked publication.
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 29 Jan 2024.