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Home Respiratory Polygraphy in Childhood Sleep Apnea-Hypopnea Syndrome (CHILDSLEEP).

NCT04340310 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2020-04-10

No results posted yet for this study

Summary

The aims of the study is to assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.

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.

Conditions

  • Sleep Apnea
  • Home Respiratory Polygraphy Sleep Study
  • Childhood Sleep Apnea
  • Polysomnography
  • Therapeutic Decision

Interventions

DIAGNOSTIC_TEST

Home respiratory polygraphy

Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission

Sponsors & Collaborators

  • Hospital Universitario San Juan de Alicante

    lead OTHER

Principal Investigators

  • Eusebi Chiner Vives · Hospital Universitario San Juan de Alicante

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2021-12-20
Completion
2022-04-06

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04340310 on ClinicalTrials.gov