Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
62 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-12-01
Study Completion Date
2025-09-17
Brief Summary
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This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children
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Detailed Description
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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.
Conditions
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Sleep Apnea, Obstructive
Sleep Disorder
Sleep Apnea Syndromes
Sleep Disturbance
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
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 Study Purpose
DIAGNOSTIC
Blinding Strategy
SINGLE
Investigators
The investigators will be masked as to the order of the two sleep tests
Study Groups
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HSAT prior to clinical sleep study
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
Group Type
EXPERIMENTAL
Home sleep apnea test
Intervention Type
DIAGNOSTIC_TEST
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
PSG first Participants will be random
Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.
Group Type
ACTIVE_COMPARATOR
PSG
Intervention Type
DIAGNOSTIC_TEST
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
Interventions
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Home sleep apnea test
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
Intervention Type
DIAGNOSTIC_TEST
PSG
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
Intervention Type
DIAGNOSTIC_TEST
Other Intervention Names
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Nox A1
HSAT
In-Lab Polysomnography
Eligibility Criteria
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Inclusion Criteria
* Male and female children age 5-12 years old inclusive
* History of adenotonsillectomy for OSA
* 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
* Children with a tracheostomy or tracheocutaneous fistula
* Children who live in a facility without their parent
Minimum Eligible Age
5 Years
Maximum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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American Academy of Sleep Medicine
OTHER
Sponsor Role
collaborator
Children's Hospital of Philadelphia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Christopher M Cielo, DO
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
Countries
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United States
References
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Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
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Other Identifiers
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22-020232
Identifier Type: -
Identifier Source: org_study_id
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