Trials / Unknown
UnknownNCT04340310
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 125 (estimated)
- Sponsor
- Hospital Universitario San Juan de Alicante · Academic / Other
- Sex
- All
- Age
- 4 Years – 14 Years
- Healthy volunteers
- —
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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Home respiratory polygraphy | Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission |
Timeline
- Start date
- 2019-02-06
- Primary completion
- 2021-12-20
- Completion
- 2022-04-06
- First posted
- 2020-04-09
- Last updated
- 2020-04-10
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04340310. Inclusion in this directory is not an endorsement.