Obstructive Sleep ApneaSAOS-21NCT07334444
Optimizing the Management of OSA in Children With Down Syndrome
An observational study of Obstructive Sleep Apnea, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The objective of this retrospective descriptive study is to assess current practices for the screening and surgical treatment of OSA in children with Down syndrome at the Strasbourg University Hospital and to disseminate a management algorithm in France. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2025to 19 Jun 2026
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: - Child with Down syndrome, aged between 0 and 17 years and having been seen for an ENT consultation at the University Hospital or the Sleep Center of the University Hospital of Strasbourg between January 1, 2019, and December 31, 2024
Who may be able to join
- Child with Down syndrome,
- Aged between 0 and 17 years,
- Having been seen for an ENT consultation at the University Hospital or the Sleep Center of the University Hospital of Strasbourg between January 1, 2019, and December 31, 2024
Who cannot join
- Presence of a written objection in the medical file of the subject (and/or their representative) to the reuse of their data for scientific research purposes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
Strasbourg, 67091
Guillaume TRAU, MD, 44, guillaume.trau@chru-strasbourg.fr
Guillaume TRAU, MD
About this study
Official title: Current Status Assessment for the Development of a Protocol to Optimize the Management of Obstructive Sleep Apnea (OSA) in Children With Down Syndrome
The objective of this retrospective descriptive study is to assess current practices for the screening and surgical treatment of OSA in children with Down syndrome at the Strasbourg University Hospital and to disseminate a management algorithm in France.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea of Child, Down syndrome
- Medical subject headings
- Sleep Apnea, Obstructive, Down Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI) before and after surgery.
The AHI is a number that indicates how many times per hour breathing is abnormal during sleep.
It adds up:
- Apneas → breathing stops completely
- Hypopneas → breathing becomes much shallower
Scores:
- AHI < 5 → normal
- AHI between 5 and 15 → mild impairment
- AHI between 15 and 30 → moderate impairment
Measured: Day 1 before surgery and Day 1 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start19 Mar 2025
- Primary completionJun 2026 (estimated)
- Study completion19 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334444
- Sponsor's protocol ID
- 9617
- Acronym
- SAOS-21
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Status Assessment for the Development of a Protocol to Optimize the Management of Obstructive Sleep Apnea (OSA) in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07334444
- Acronym / sponsor ID
- SAOS-21 / 9617
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea of Child, Down syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 19 Jun 2026 (estimated)
- First posted
- 12 Jan 2026 (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 objective of this retrospective descriptive study is to assess current practices for the screening and surgical treatment of OSA in children with Down syndrome at the Strasbourg University Hospital and to disseminate a management algorithm in France.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- - Child with Down syndrome, aged between 0 and 17 years and having been seen for an ENT consultation at the University Hospital or the Sleep Center of the University Hospital of Strasbourg between January 1, 2019, and December 31, 2024
Key inclusion criteria (3 listed)
- Child with Down syndrome,
- Aged between 0 and 17 years,
- Having been seen for an ENT consultation at the University Hospital or the Sleep Center of the University Hospital of Strasbourg between January 1, 2019, and December 31, 2024
Key exclusion criteria (1 listed)
- Presence of a written objection in the medical file of the subject (and/or their representative) to the reuse of their data for scientific research purposes.
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 (AHI) before and after surgery.
Time frame: Day 1 before surgery and Day 1 after surgery
The AHI is a number that indicates how many times per hour breathing is abnormal during sleep. It adds up: * Apneas → breathing stops completely * Hypopneas → breathing becomes much shallower Scores: * AHI < 5 → normal * AHI between 5 and 15 → mild impairment * AHI between 15 and 30 → moderate impairment
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 12 Jan 2026.
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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.
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 Obstructive Sleep Apnea, run by University Hospital, Strasbourg, France at 1 site in France.
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 12 Jan 2026. 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 France. 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 Guillaume TRAU, MD (33 3 88 12 76 44, guillaume.trau@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (AHI) before and after surgery. (time frame: Day 1 before surgery and Day 1 after surgery). 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 12 Jan 2026.