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

Hospital Universitario San Juan de Alicante

Status: Unknown

Conditions: Polysomnography; Home Respiratory Polygraphy Sleep Study; Sleep Apnea; Childhood Sleep Apnea; Therapeutic Decision

Treatments: Diagnostic Test: Home respiratory polygraphy

Study type: Observational

Funder types: Other

Identifiers

NCT04340310

CEIC (HUSJ-20-003)

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

125 participants in 2 patient groups

Home respiratory poligraphy

Description:

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

Treatment:

Diagnostic Test: Home respiratory polygraphy

Polysomnography

Description:

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

Treatment:

Diagnostic Test: Home respiratory polygraphy