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

• Conditions: Home Respiratory Polygraphy Sleep Study; Childhood Sleep Apnea; Therapeutic Decision; Sleep Apnea; Polysomnography
• Interventions: Diagnostic Test: Home respiratory polygraphy

• Registration Number: NCT04340310
• Lead Sponsor: Hospital Universitario San Juan de Alicante

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-06
• Status Verified: 2020-04
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-08
• Last Update Submitted: 2020-04-08
• Study First Posted: 2020-04-09
• Last Update Posted: 2020-04-10
• Primary Completion: 2021-12-20
• Study Completion: 2022-04-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Home respiratory poligraphy	Home respiratory polygraphy	Group A: Children between 4 and 14 years-old with initial OSA suspicion there will be allocated to Home Respiratory Polygraphy (HRP)
Polysomnography	Home respiratory polygraphy	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

Primary Outcome Measures

Name	Time	Method
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 years	False negative and true positive diagnosis by home respiratory polygraphy

Secondary Outcome Measures

Name	Time	Method
To assess the prevalence of childhood sleep apnea in Pneumology hospital consultations	two years	Number of chlidhood sleep consultations related to adult consultations

Trial Locations

Locations (1)

Eusebio Chiner Vives; 🇪🇸 San Juan de Alicante, Alicante, Spain