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

Usefulness of Home Respiratory Polygraphy in the Diagnosis and Therapeutic Decision of Childhood Sleep Apnea-Hypopnea Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04340310
Acronym
CHILDSLEEP
Enrollment
125
Registered
2020-04-09
Start date
2019-02-06
Completion date
2022-04-06
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Childhood sleep apnea, Sleep apnea syndrome, Obstructive apnea syndrome, Obstructive apnea sleep

Brief 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.

Interventions

Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission

Sponsors

Hospital Universitario San Juan de Alicante
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 14 Years

Inclusion criteria

* Sleep apnea suspicion

Exclusion criteria

* Other sleep conditions * Non valid home respiratory polygraphy and non valid polysomnography in the same patient * Non informated consent

Design outcomes

Primary

MeasureTime frameDescription
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.two yearsFalse negative and true positive diagnosis by home respiratory polygraphy

Secondary

MeasureTime frameDescription
To assess the prevalence of childhood sleep apnea in Pneumology hospital consultationstwo yearsNumber of chlidhood sleep consultations related to adult consultations

Countries

Spain

Contacts

Primary ContactEusebi Chiner Vives, MD, PhD
echinervives@gmail.com609017275

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026