Feasibility of comprehensive, unattended ambulatory polysomnography in school-aged children.
Carole L Marcus, Joel Traylor, Sarah N Biggs...
https://pubmed.ncbi.nlm.nih.gov/25126039Actively Recruiting
Phase Not Applicable
Age: 5Years - 12Years
All Genders
ID05382754
Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
Led by Children's Hospital of Philadelphia · Updated on 2026-04-21
317
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating home sleep apnea testing (HSAT) compared to the standard in-lab polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA) in children aged 5 to 12 years. This trial aims to compare the accuracy of HSAT and PSG, how each test influences treatment decisions, and how acceptable and preferable these tests are to both children and their parents. The study is conducted because PSG, while the recommended method, is costly and not widely accessible, leading to many children undergoing treatment without a formal diagnosis. Participants will be randomly assigned to either have the HSAT before their clinical PSG or after it. Both tests will be completed within one week. The HSAT involves a level II home sleep apnea test conducted at home with parental supervision, while PSG is an overnight sleep study in a lab with continuous monitoring by clinical staff. Pediatric sleep medicine doctors will review clinical data along with either HSAT or PSG results to make treatment decisions. During the study, families will complete questionnaires about how acceptable HSAT is and which test they prefer. The primary outcome is the proportion of participants diagnosed with OSA by both HSAT and PSG within two weeks. Secondary outcomes include the agreement in treatment decisions between the two tests, participant preference for HSAT, and the correlation of apnea severity indices between HSAT and PSG. The study monitors participants closely during this short period, with all procedures completed within about two weeks.
CONDITIONS
Brief Title
Home Apnea Testing in CHildren Trial
Who Can Participate
Age: 5Years - 12Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female children age 5-12 years old inclusive
- Referred for diagnostic PSG at the Children's Hospital of Philadelphia Sleep Laboratory for evaluation of obstructive sleep apnea
- Parental or guardian permission (informed consent) and child assent when appropriate
You will not qualify if you...
- Children without Down syndrome who have had a PSG within 3 years of enrollment
- Children with Down syndrome who have had a PSG within 1 year of enrollment
- Children with a history of hypoventilation, 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 2 weeks
Participants undergo two types of sleep apnea tests, home sleep apnea testing (HSAT) and in-lab polysomnography (PSG), to evaluate for obstructive sleep apnea.
2 visits within 1 week, one for each test (HSAT and PSG)
Trial Site Locations
Total: 1 location
1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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Research Team
C
Christopher M Cielo, DO
I
Ignacio E Tapia, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Feasibility of using unattended polysomnography in children for research--report of the Tucson Children's Assessment of Sleep Apnea study (TuCASA).
J L Goodwin, P L Enright, K L Kaemingk...
https://pubmed.ncbi.nlm.nih.gov/11766164Pediatric obstructive sleep apnea syndrome.
Christian Guilleminault, Ji Hyun Lee, Allison Chan
https://pubmed.ncbi.nlm.nih.gov/16061787Sleep disordered breathing in children in a general population sample: prevalence and risk factors.
Edward O Bixler, Alexandros N Vgontzas, Hung-Mo Lin...
https://pubmed.ncbi.nlm.nih.gov/19544748Epidemiology of obstructive sleep apnoea syndrome in Chinese children: a two-phase community study.
Albert M Li, Hung K So, Chun T Au...
https://pubmed.ncbi.nlm.nih.gov/20965935Elevated blood pressure during sleep and wake in children with sleep-disordered breathing.
Rosemary S C Horne, Joel S C Yang, Lisa M Walter...
https://pubmed.ncbi.nlm.nih.gov/21708802A randomized trial of adenotonsillectomy for childhood sleep apnea.
Carole L Marcus, Reneé H Moore, Carol L Rosen...
https://pubmed.ncbi.nlm.nih.gov/23692173C-reactive protein, obstructive sleep apnea, and cognitive dysfunction in school-aged children.
David Gozal, Valerie McLaughlin Crabtree, Oscar Sans Capdevila...
https://pubmed.ncbi.nlm.nih.gov/17400731Diagnosis and management of childhood obstructive sleep apnea syndrome.
Carole L Marcus, Lee Jay Brooks, Kari A Draper...
https://pubmed.ncbi.nlm.nih.gov/22926173Pediatric polysomnography: the patient and family perspective.
Shubhadeep Das, Jodi Mindell, Genevieve C Millet...
https://pubmed.ncbi.nlm.nih.gov/21344042