Clinical trial NCT05516524: HSAT for OSA Management in Children
Official title: Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sleep Disorder
Sleep Apnea Syndromes
Sleep Disturbance
Keywords: obstructive sleep apnea
home sleep apnea testing
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2022-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within approximately one week.
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG
timeFrame: up to one month
Secondary outcomes:
measure: Correlation between OAHI from HSAT and score from OSA questionnaires
timeFrame: up to one month
measure: Parent-reported preference between HSAT and PSG
timeFrame: up to one month
measure: Child-reported preference between HSAT and PSG
timeFrame: up to one month
measure: Parent-reported acceptability of HSAT
timeFrame: up to one month.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Christopher M Cielo, DO
role: PRINCIPAL_INVESTIGATOR
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