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Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome (SAOS/T21)

This study is currently recruiting participants.
Verified January 2013 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00951730
First received: August 3, 2009
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

People with Down syndrome are at increased risk of sleep apnea, not only from obstruction of the upper airway, but also of central origin. According to published data, sleep apnea may occur in at least 40% of children and adults with Down syndrome. Consequences of these sleep apnea are numerous : failure to thrive, cognitive decline, high blood pressure, heart disease, accident due to day sleepiness, fatigue. This condition is treatable in people with Down syndrome, as it is in ordinary people.

Diagnosis of sleep apnea in people with Down syndrome is therefore a major concern. In addition, data regarding age of apparition of this complication are missing, making repeated screening necessary.

Polysomnography is the method of choice for the diagnosis of sleep apnea. Unfortunately, it is time consuming and sleep departments are heavily busy.


Condition Intervention
Down Syndrome
 Other: Polysomnography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Apnea / hypopnea events index determined by reading the complete polysomnography (review reference) and apnea / hypopnoea events index determined by the simplified five parameters of the polysomnography [ Time Frame: At 15 days after enroling ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaire on sleep [ Time Frame: At inclusion and at the end (18 months) ] [ Designated as safety issue: No ]
  • Psychometric tests [ Time Frame: At inclusion and at the end (18 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Down syndrome
Adult and children with Down syndrome.
 Other: Polysomnography
Polysomnography is the method of choice for the diagnosis of sleep apnea. This test lasts for one night in hospital.

Detailed Description:

The main objective of our study is to evaluate an easier screening strategy combining questionnaire and overnight recording of few data, compared to polysomnography.

We hope our strategy will permit regular screening for people with Down syndrome, helping us to draw guidelines for the survey of sleep apnea in this population.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Down syndrome

Criteria

Inclusion Criteria:

  • Down syndrome
  • Patient (or parents of children) affiliated in a Social Regimen
  • Written consent signed (by parents for the children)

Exclusion Criteria:

  • Severe heart failure
  • Insufficient autonomy
  • Diagnosis of insanity, or behavioural problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951730

Contacts
Contact: Benedicte DE FREMINVILLE, MD +33(0)477828048 benedicte.de.freminville@chu-st-etienne.fr
Contact: Arnauld GARCIN, CRA +33(0)477120286 agarcin34@yahoo.fr

Locations
France
CHU de Grenoble Recruiting
Grenoble, France, 38000
Principal Investigator: Jean-Louis PEPIN, MD PhD            
Hospices Civiles de lyon Recruiting
Lyon, France, 69000
Principal Investigator: Damien SANLAVILLE, MD            
Sub-Investigator: Patricia FRANCO, MD            
CHU de Saint-Etienne Recruiting
Saint-etienne, France, 42055
Principal Investigator: Benedicte De FREMINVILLE, MD            
Sub-Investigator: Renaud TOURAINE, MD            
Sub-Investigator: Isabelle COURT-FORTUNE, MD            
Sub-Investigator: Frédéric ROCHE, MD PhD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Benedicte De Freminville, MD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00951730     History of Changes
Other Study ID Numbers: 0808017, 2008-A01273-52
Study First Received: August 3, 2009
Last Updated: January 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Down Syndrome
Adult
Children
 Sleep apnea
Sleep hypopnea
Polysomnography

Additional relevant MeSH terms:
Down Syndrome
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Mental Retardation
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

ClinicalTrials.gov processed this record on June 17, 2013