Down SyndromeRESPIRE21NCT03210675
Early Detection and Treatment of Obstructive Sleep Apnoea in Infants With Down Syndrome
A study testing Polysomnography (PSG) in people with Down Syndrome and Obstructive Sleep Apnea of Newborn, run by Institut Jerome Lejeune at 1 site in France.
Trial summary
Interventional, comparative, open-label, single-center study to demonstrate that early (from 6 months of age) and systematic (every 6 months) screening for Obstructive Sleep Apnoea (OSA) by polysomnography (PSG) in infants with Down syndrome during the first 3 years of life is associated with improved neurodevelopment… Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Down Syndrome, Obstructive Sleep Apnea of Newborn
- What is being tested?
- Polysomnography (PSG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2017to 29 Feb 2024
- Phase
- Interventional
- 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 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Down Syndrome Age 6 months or less for the Study Group Age 30 to 36 months for the Standard Care Group Living in Paris or Paris area (75, 77, 78, 92, 93, 94, 95) Parents or legal representative agreeing with the study requirements and able to understand, date and sign the informed consent form before study enrollment French language is native mother tongue
Who cannot join
- Gestationnel age < 36 completed amenorrhoea weeks Patient who have or had acute CNS suffering signs Patients with Down Syndrome already had continuous positive airway pressure treatment for OSA Patients participating in another clinical study or for whom a participation to another biomedical research is expected before the end or their follow-up
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Jérome Lejeune
Paris, Sélectionnez l'État/Province, 75015
About this study
Interventional, comparative, open-label, single-center study to demonstrate that early (from 6 months of age) and systematic (every 6 months) screening for Obstructive Sleep Apnoea (OSA) by polysomnography (PSG) in infants with Down syndrome during the first 3 years of life is associated with improved neurodevelopment at 3 years of age, with sustained benefits up to 5 years of age.
- Conditions
- Down Syndrome, Obstructive Sleep Apnea of Newborn
- Being tested
- Polysomnography (PSG)
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography (PSG)Diagnostic test
PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years. Receives: Diagnostic Test: Polysomnography (PSG) |
| Standard Care Group | Other | Will have a single PSG at home which will give a reference in the Down Syndrome population of 3 years old and will be used as reference to the study group Receives: Diagnostic Test: Polysomnography (PSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Griffiths Scales of Child Development, Third Edition (Griffiths III) Scores
Median Griffiths III scores at the age of 3 years will be compared between the 2 groups
Measured: At the age of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start31 Jul 2017
- Primary completion30 Jun 2022
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, comparative, open label, multi-center study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Jerome Lejeune
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Responsible party
- Sponsor
- Investigators
- Brigitte FAUROUX, Professor, Study chair, Hôpital Necker-Enfants MaladeClotilde MIRCHER, Doctor, Principal investigator, Institut Jérôme Lejeune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210675
- Sponsor's protocol ID
- DP-TRS-T21
- Acronym
- RESPIRE21
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2017
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lal C, White DR, Joseph JE, van Bakergem K, LaRosa A. Sleep-disordered breathing in Down syndrome. Chest. 2015 Feb;147(2):570-579. doi: 10.1378/chest.14-0266.
PubMed 25644910Bertrand P, Navarro H, Caussade S, Holmgren N, Sanchez I. Airway anomalies in children with Down syndrome: endoscopic findings. Pediatr Pulmonol. 2003 Aug;36(2):137-41. doi: 10.1002/ppul.10332.
PubMed 12833493Fricke BL, Donnelly LF, Shott SR, Kalra M, Poe SA, Chini BA, Amin RS. Comparison of lingual tonsil size as depicted on MR imaging between children with obstructive sleep apnea despite previous tonsillectomy and adenoidectomy and normal controls. Pediatr Radiol. 2006 Jun;36(6):518-23. doi: 10.1007/s00247-006-0149-7. Epub 2006 Apr 5.
PubMed 16596369Shires CB, Anold SL, Schoumacher RA, Dehoff GW, Donepudi SK, Stocks RM. Body mass index as an indicator of obstructive sleep apnea in pediatric Down syndrome. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):768-72. doi: 10.1016/j.ijporl.2010.03.050. Epub 2010 May 7.
PubMed 20452066Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
PubMed 22926176Breslin J, Spano G, Bootzin R, Anand P, Nadel L, Edgin J. Obstructive sleep apnea syndrome and cognition in Down syndrome. Dev Med Child Neurol. 2014 Jul;56(7):657-64. doi: 10.1111/dmcn.12376. Epub 2014 Jan 29.
PubMed 24471822Bull MJ; Committee on Genetics. Health supervision for children with Down syndrome. Pediatrics. 2011 Aug;128(2):393-406. doi: 10.1542/peds.2011-1605. Epub 2011 Jul 25.
PubMed 21788214Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.
PubMed 18296460Fauroux B, Sacco S, Couloigner V, Amaddeo A, Ravel A, Prioux E, Toulas J, Cieuta-Walti C, Walti H, Luscan R, Falquero S, Clert M, Caillaud MA, De Sanctis L, Khirani S, Marey I, Mircher C. Early detection and treatment of obstructive sleep apnoea in infants with Down syndrome: a prospective, non-randomised, controlled, interventional study. Lancet Reg Health Eur. 2024 Aug 21;45:101035. doi: 10.1016/j.lanepe.2024.101035. eCollection 2024 Oct.
PubMed 39262447
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Treatment of Obstructive Sleep Apnoea in Infants With Down Syndrome
- ClinicalTrials.gov ID
- NCT03210675
- Acronym / sponsor ID
- RESPIRE21 / DP-TRS-T21
- Conditions
- Down Syndrome, Obstructive Sleep Apnea of Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institut Jerome LejeuneUniversity, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 7 Jul 2017 (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.
Interventional, comparative, open-label, single-center study to demonstrate that early (from 6 months of age) and systematic (every 6 months) screening for Obstructive Sleep Apnoea (OSA) by polysomnography (PSG) in infants with Down syndrome during the first 3 years of life is associated with improved neurodevelopment at 3 years of age, with sustained benefits up to 5 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, comparative, open label, multi-center study
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Diagnostic Test: Polysomnography (PSG)Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years. |
| Standard Care Group | Other | Diagnostic Test: Polysomnography (PSG)Will have a single PSG at home which will give a reference in the Down Syndrome population of 3 years old and will be used as reference to the study group |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Down Syndrome Age 6 months or less for the Study Group Age 30 to 36 months for the Standard Care Group Living in Paris or Paris area (75, 77, 78, 92, 93, 94, 95) Parents or legal representative agreeing with the study requirements and able to understand, date and sign the informed consent form before study enrollment French language is native mother tongue
Key exclusion criteria (1 listed)
- Gestationnel age < 36 completed amenorrhoea weeks Patient who have or had acute CNS suffering signs Patients with Down Syndrome already had continuous positive airway pressure treatment for OSA Patients participating in another clinical study or for whom a participation to another biomedical research is expected before the end or their follow-up
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 |
|---|---|---|
| Polysomnography (PSG)PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years | Diagnostic test | Standard Care Group, Study group |
Primary outcome
Median Griffiths Scales of Child Development, Third Edition (Griffiths III) Scores
Time frame: At the age of 3 years
Median Griffiths III scores at the age of 3 years will be compared between the 2 groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 25644910Lal C, White DR, Joseph JE, van Bakergem K, LaRosa A. Sleep-disordered breathing in Down syndrome. Chest. 2015 Feb;147(2):570-579. doi: 10.1378/chest.14-0266.
- Background: PubMed 12833493Bertrand P, Navarro H, Caussade S, Holmgren N, Sanchez I. Airway anomalies in children with Down syndrome: endoscopic findings. Pediatr Pulmonol. 2003 Aug;36(2):137-41. doi: 10.1002/ppul.10332.
- Background: PubMed 16596369Fricke BL, Donnelly LF, Shott SR, Kalra M, Poe SA, Chini BA, Amin RS. Comparison of lingual tonsil size as depicted on MR imaging between children with obstructive sleep apnea despite previous tonsillectomy and adenoidectomy and normal controls. Pediatr Radiol. 2006 Jun;36(6):518-23. doi: 10.1007/s00247-006-0149-7. Epub 2006 Apr 5.
- Background: PubMed 20452066Shires CB, Anold SL, Schoumacher RA, Dehoff GW, Donepudi SK, Stocks RM. Body mass index as an indicator of obstructive sleep apnea in pediatric Down syndrome. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):768-72. doi: 10.1016/j.ijporl.2010.03.050. Epub 2010 May 7.
- Background: PubMed 22926176Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
- Background: PubMed 24471822Breslin J, Spano G, Bootzin R, Anand P, Nadel L, Edgin J. Obstructive sleep apnea syndrome and cognition in Down syndrome. Dev Med Child Neurol. 2014 Jul;56(7):657-64. doi: 10.1111/dmcn.12376. Epub 2014 Jan 29.
- Background: PubMed 21788214Bull MJ; Committee on Genetics. Health supervision for children with Down syndrome. Pediatrics. 2011 Aug;128(2):393-406. doi: 10.1542/peds.2011-1605. Epub 2011 Jul 25.
- Background: PubMed 18296460Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.
- Results publication: PubMed 39262447Fauroux B, Sacco S, Couloigner V, Amaddeo A, Ravel A, Prioux E, Toulas J, Cieuta-Walti C, Walti H, Luscan R, Falquero S, Clert M, Caillaud MA, De Sanctis L, Khirani S, Marey I, Mircher C. Early detection and treatment of obstructive sleep apnoea in infants with Down syndrome: a prospective, non-randomised, controlled, interventional study. Lancet Reg Health Eur. 2024 Aug 21;45:101035. doi: 10.1016/j.lanepe.2024.101035. eCollection 2024 Oct.
- Sponsor and site investigatorLink provided by the sponsor.
- Site investigator for PSG evaluationLink provided by the sponsor.
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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.
Brigitte FAUROUX, Professor study chair
Hôpital Necker-Enfants Malade
Clotilde MIRCHER, Doctor principal investigator
Institut Jérôme Lejeune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography (PSG) in people with Down Syndrome and Obstructive Sleep Apnea of Newborn, run by Institut Jerome Lejeune 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 1 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: finished, as of the sponsor's last update on 21 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Median Griffiths Scales of Child Development, Third Edition (Griffiths III) Scores (time frame: At the age of 3 years). 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 NCT03210675, which also lists 9 linked publications.
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 21 Sep 2026.