Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome

NCT ID: NCT03210675

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2024-06-30

Brief Summary

Interventional, comparative, open label, single-center study to demonstrate that an early (from 6 months of age) and systematic (every 6 months) screening of Obstructive Sleep Apnea (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of life is associated with an improved neurocognitive development at the age of 3 years.

Conditions

Down Syndrome; Obstructive Sleep Apnea of Newborn

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study group

Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years.

Group Type: OTHER

Polysomnography (PSG)

Intervention Type: DIAGNOSTIC_TEST

PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years

Standard Care Group

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

Group Type: OTHER

Polysomnography (PSG)

Intervention Type: DIAGNOSTIC_TEST

PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years

Interventions

Polysomnography (PSG)

PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Necker-Enfants Malades

OTHER

Sponsor Role: collaborator

Institut Jerome Lejeune

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte FAUROUX, Professor

Role: STUDY_CHAIR

Hôpital Necker-Enfants Malade

Clotilde MIRCHER, Doctor

Role: PRINCIPAL_INVESTIGATOR

Institut Jérôme Lejeune

Locations

Institut Jérome Lejeune

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 25644910 (View on PubMed)

Bertrand 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.

Reference Type: BACKGROUND

PMID: 12833493 (View on PubMed)

Fricke 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.

Reference Type: BACKGROUND

PMID: 16596369 (View on PubMed)

Shires 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.

Reference Type: BACKGROUND

PMID: 20452066 (View on PubMed)

Marcus 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.

Reference Type: BACKGROUND

PMID: 22926176 (View on PubMed)

Breslin 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.

Reference Type: BACKGROUND

PMID: 24471822 (View on PubMed)

Bull 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.

Reference Type: BACKGROUND

PMID: 21788214 (View on PubMed)

Ellis 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.

Reference Type: BACKGROUND

PMID: 18296460 (View on PubMed)

Related Links

http://www.institutlejeune.org/

Sponsor and site investigator

http://vnietsommeil.aphp.fr/

Site investigator for PSG evaluation

Other Identifiers

DP-TRS-T21

Identifier Type: -

Identifier Source: org_study_id