Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development (SAOS)

February 6, 2020 updated by: Rennes University Hospital
Assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated. Furthermore, detecting OSA remains difficult due to its particular physiopathology. The decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is to show that reducing sleep apnea in children remains possible when inducing rapid palatal expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates a mandibular advancement appliance and repositioning of the patient during sleep.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 5 to 7 year-old children
  • Children with American Society of Anesthesiologists score (ASA) of 1 and 2
  • Children with signs of OSA during examination and clinical exam
  • Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour during PSG)
  • Children with a class II division 1 angle malocclusion (at the canines level rotation center) and skeletal class II according to Delaire analysis

Exclusion Criteria:

  • OSA associated to syndromic disorder and/or syndrome
  • Body/Mass Index (BMI) > 97ème percentile according to development curves (obese children)
  • Central sleep apnea
  • Respiratory allergy
  • Previous ear, nose and throat (ENT) surgery
  • Hypertrophic tonsils needing surgery
  • Adenoid hypertrophy needing surgery
  • Patients with ankyloglossia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient with OSA
Device: Rapid palatal expansion
Fixation of rapid palatal expansion from day 0 to day 60
Device: MGA™ system
Use of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained)
Device: Yoobreath™ system
Use of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)
Time Frame: Day 180
Day 180
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with a device allowing a semi-seated sleeping position (YooBreath™)
Time Frame: Day 180
Day 180

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep improvement
Time Frame: Day -7, day 180
Measurement by polysomnography of desaturation index, micro arousal index and snoring index
Day -7, day 180
Assessment of quality of sleep
Time Frame: Day 180
Assessment of quality of sleep by a questionnaire
Day 180
Assessment of quality of wakefulness
Time Frame: Day 180
Assessment of quality of wakefulness by a questionnaire
Day 180
Measurement of lengthening of mandibular body and ramus
Time Frame: Day -7, day 180
Assessment of mandible development by an orthodontist using cephalometric analysis
Day -7, day 180
Improvement of breathing
Time Frame: Day -7, day 180
Improvement of breathing defined by polysomnography
Day -7, day 180
Assessment of dental occlusion
Time Frame: Day -7, day 180
Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class
Day -7, day 180
Assessement by the child and the parents of the treatment and the devices used
Time Frame: Day 180
Assessement by the child and the parents of the treatment and the devices used by two questionnaires (one for parents and one for the child)
Day 180
Assessment of intensity of pain during rapid palatal expansion
Time Frame: Day 60
Assessment of intensity of pain after fixing of rapid palatal expansion using a Visual Analogue Scale (VAS)
Day 60
Assessment of duration of pain during rapid palatal expansion
Time Frame: Day 60
Number of painful days after fixing of rapid palatal expansion
Day 60
Assessment of intensity of dental pain the morning on waking after using the MGA™ system
Time Frame: Day 60, day 90, day 120, day 150, day 180
Assessment of intensity of dental pain the morning on waking using a Visual Analogue Scale (VAS)
Day 60, day 90, day 120, day 150, day 180
Assessment of salivary disorders the morning on waking after using the MGA™ system
Time Frame: Day 60, day 90, day 120, day 150, day 180
Assessment of salivary disorders the morning on waking by a questionnaire
Day 60, day 90, day 120, day 150, day 180
Assessment of duration of dental pain the morning on waking after using the MGA™ system
Time Frame: Day 60, day 90, day 120, day 150, day 180
Number of painful days at the mandible the morning on waking
Day 60, day 90, day 120, day 150, day 180
Assessment of pain related to the semi-seated position
Time Frame: Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS)
Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of disorders in falling asleep and sleep quality (micro arousals)
Time Frame: Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of disorders in falling asleep and sleep quality (micro arousals) by a questionnaire
Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of risk of falling using the Yoobreath system™
Time Frame: Day 15, day 60, day 90, day 120, day 150, day 180
Number of falls
Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of the compliance
Time Frame: Day 0, day 15, day 60, day 90, day 120, day 150, day 180
Reporting of side effects
Day 0, day 15, day 60, day 90, day 120, day 150, day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC16_9851_SAOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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