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Trial record 81 of 165 for:    trisomy21 NOT prenatal

Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue

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ClinicalTrials.gov Identifier: NCT02732431
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

Brief Summary:

Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric practice, there is no way to determine the children with an increased risk. The aim of the study is to determine the reliability of four questionnaires used in pediatric patients in screening of OSA in Down syndrome children.

Prospective study where patients are evaluated on airway diseases and aeroallergens sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an overnight polysomnography (PSG), in University Hospital in Nice.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: Sleep Symptom Not Applicable

Detailed Description:

Introduction: Children with Down syndrome (DS) commonly have obstructive sleep apnea (OSA) though undervalued by parents and physicians. Several sleep questionnaires are used in paediatric patients to detect high risk children who have OSA, but not really appropriate for DS patients. The aim of the study is to determine the reliability of four questionnaires used in paediatric patients (PSQ-SRBD: Pediatric Sleep Questionnaire-Sleep-Related Breathing Disorder, CSHQ: Children's Sleep Habits Questionnaire, CAS-15: Clinical Assessment Score-15 and SCR: Sleep Clinical Record) in screening of OSA in DS population.

Study design: Prospective study concerning children with Down syndrome (age 1-18y). Parents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Obstructive Sleep Apnea Screening and Down Syndrome in Childhood : the Reliability of the Clinical Examination
Actual Study Start Date : October 10, 2013
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
trisomy 21
Parents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice.
Other: Sleep Symptom
Questionnaires, skin allergy test, overnight polysomnography




Primary Outcome Measures :
  1. determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population [ Time Frame: At the inclusion ]
    Sensitivity each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.


Secondary Outcome Measures :
  1. determine the reliability of the specificity of four questionnaires used in paediatric patients in screening of OSA in DS population [ Time Frame: At the inclusion ]
    specificity of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.

  2. determine the reliability of positive predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population [ Time Frame: At the inclusion ]
    positive predictive value of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.

  3. determine the reliability of negative predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population [ Time Frame: At the inclusion ]
    negative predictive value of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.

  4. determine the reliability of positive likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population [ Time Frame: At the inclusion ]
    positive likelihood of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.

  5. determine the reliability of negative likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population [ Time Frame: At the inclusion ]
    negative likelihood ratio of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.

  6. determine the reliability of area under a receiver operating characteristic (ROC) curve of four questionnaires used in paediatric patients in screening of OSA in DS population [ Time Frame: At the inclusion ]
    area under a receiver operating characteristic (ROC) curve of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age under 18 years
  • Down syndrome with cytogenetic diagnosis
  • State health cover
  • Consent of legal representative and/or patient

Exclusion Criteria:

  • Polysomnography with correct results during the 12 months before

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732431


Locations
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France
CHU de Nice
Nice, Alpes-Maritimes, France, 06000
Sponsors and Collaborators
Fondation Lenval
Investigators
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Principal Investigator: lisa CHAMI, MD Hôpitaux Pédiatriques de Nice CHU-LENVAL

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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT02732431     History of Changes
Other Study ID Numbers: 14-HPNCL-06
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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