Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults (TRSPed)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Sleep-disordered Breathing (SDB)

Treatments: Other: Sleep study

Study type: Interventional

Funder types: Other

Identifiers

NCT04971850

APHP210042

2020-A03083-36 (Other Identifier)

Details and patient eligibility

About

One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB.

The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.

Full description

One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB.

In addition, the clinical impact of SDB and the benefit of treatment are still not clear in children and young adults, including neurocognitive and developmental perspective.

Finally, the validation of simplified tools could optimize and simplify the detection of SDB in children and young adults.

Patients scheduled to perform a diagnostic PSG for routine clinical care will have additional recordings and questionnaires as part of the study.

The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 1 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 1 to 20 years with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study
• Written informed consent

Exclusion criteria

• No social insurance
• Significant psychomotor retardation
• Cooperation not possible
• Significant agitation
• Acute condition and/or temporary drug treatments that may interfere with the results of PSG (upper or lower airway infection)
• Patient under guardianship/curatorship

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,200 participants in 1 patient group

Sleep-disordered breathing (SDB)

Experimental group

Description:

Patients aged 1 to 20 years old with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study for their clinical care.

Treatment:

Other: Sleep study