HSAT for OSA Management in Children (HOM-Kids)

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Sleep Apnea Syndromes; Sleep Disorder; Sleep Apnea, Obstructive; Sleep Disturbance

Treatments: Diagnostic Test: PSG; Diagnostic Test: Home sleep apnea test

Study type: Interventional

Funder types: Other

Identifiers

NCT05516524

22-020232

Details and patient eligibility

About

This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children

Full description

Many children have residual obstructive sleep apnea (OSA) following adenotonsillectomy, but in-lab polysomnography (PSG), the recommended means of re-evaluating these patients, is resource-intensive and availability is limited. Home sleep apnea testing (HSAT), a similar test performed in the patient's home and used clinically in adults, may offer an alternative means of evaluating the effect of OSA treatment in children and make testing more convenient and widely available.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female children age 5-12 years old inclusive
• History of adenotonsillectomy for OSA

Exclusion criteria

• Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep
• Children with a tracheostomy or tracheocutaneous fistula
• Children who live in a facility without their parent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

HSAT prior to clinical sleep study

Experimental group

Description:

Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography

Treatment:

Diagnostic Test: Home sleep apnea test

PSG first Participants will be random

Active Comparator group

Description:

Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.

Treatment:

Diagnostic Test: PSG