Home Respiratory Polygraphy in Childhood Sleep Apnea-Hypopnea Syndrome (CHILDSLEEP).
NCT ID: NCT04340310
Last Updated: 2020-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
125 participants
OBSERVATIONAL
2019-02-06
2022-04-06
Brief Summary
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Methods: Children referred with suspected OSAS will be evaluated during one year performing home respiratory polygraphy in all cases. PSG will be chosen in patients with concomitant pathology or according to medical criteria, or complemented with HRP in doubtful cases. Clinical and anthropometric data, severity, technical quality and treatment will be obtained. Patients will be divided in two groups (HRP vs PSG) and compared, and the accuracy from HRP to establish a therapeutic decision it wil calculated. The investigator's hypothesis is that PSG should be recommended only for complex or doubtful cases.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Home respiratory poligraphy
Group A: Children between 4 and 14 years-old with initial OSA suspicion there will be allocated to Home Respiratory Polygraphy (HRP)
Home respiratory polygraphy
Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission
Polysomnography
Group B: Children between 4 and 14 years-old with initial OSA suspicion and concommitant diseases and false negative suspicion from HRP there will allocated to Hospital Nocturnal Polysomnography
Home respiratory polygraphy
Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission
Interventions
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Home respiratory polygraphy
Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non valid home respiratory polygraphy and non valid polysomnography in the same patient
* Non informated consent
4 Years
14 Years
ALL
No
Sponsors
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Hospital Universitario San Juan de Alicante
OTHER
Responsible Party
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Eusebi Chiner
Head of Pneumology
Principal Investigators
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Eusebi Chiner Vives
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario San Juan de Alicante
Locations
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Eusebio Chiner Vives
Sant Joan d'Alacant, Alicante, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CEIC (HUSJ-20-003)
Identifier Type: -
Identifier Source: org_study_id
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