NCT04340310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2022

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

April 6, 2020

Last Update Submit

April 8, 2020

Conditions

Sleep ApneaHome Respiratory Polygraphy Sleep StudyChildhood Sleep ApneaPolysomnographyTherapeutic Decision

Keywords

Childhood sleep apneaSleep apnea syndromeObstructive apnea syndromeObstructive apnea sleep

Outcome Measures

Primary Outcomes (1)

  • 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.

    False negative and true positive diagnosis by home respiratory polygraphy

    two years

Secondary Outcomes (1)

  • To assess the prevalence of childhood sleep apnea in Pneumology hospital consultations

    two years

Study Arms (2)

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)

Diagnostic Test: Home respiratory polygraphy

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

Diagnostic Test: Home respiratory polygraphy

Interventions

Home respiratory polygraphyDIAGNOSTIC_TEST

Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission

Also known as: Polysomnography
Home respiratory poligraphyPolysomnography

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children submited to Pneumology Service with sleep apnea suspicion

You may qualify if:

  • Sleep apnea suspicion

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eusebio Chiner Vives

Sant Joan d'Alacant, Alicante, 03550, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Eusebi Chiner Vives

    Hospital Universitario San Juan de Alicante

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eusebi Chiner Vives, MD, PhD

CONTACT

609017275echinervives@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pneumology

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

February 6, 2019

Primary Completion

December 20, 2021

Study Completion

April 6, 2022

Last Updated

April 10, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

Scientific publication, Sleep spanish network

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
5 years

Locations

ES(1)