Portable monitoring and autotitration versus polysomnography for the diagnosis and treatment of sleep apnea.
Richard B Berry, Gilbert Hill, Linda Thompson...
https://pubmed.ncbi.nlm.nih.gov/18853940/Actively Recruiting
Led by Children's Hospital of Philadelphia · Updated on 2026-04-21
317
Participants Needed
1
Research Sites
30 weeks
Total Duration
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
Home Apnea Testing in CHildren Trial
C
Christopher M Cielo, DO
I
Ignacio E Tapia, MD
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Children's Hospital of Philadelphia
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Home Sleep Apnea Test (HSAT) | In-Lab Polysomnography (PSG) |
|---|---|---|
| What it is | A portable sleep apnea test performed at home with parental supervision to record sleep parameters and detect obstructive sleep apnea. | A comprehensive overnight sleep study conducted in a laboratory setting with continuous clinical monitoring, used as the gold standard for diagnosing obstructive sleep apnea. |
| Role in trial | Evaluated as a less burdensome alternative diagnostic method compared to in-lab PSG for children referred for OSA assessment. | Serves as the reference standard in the study, against which HSAT results are compared. |
| Primary use | Screening and diagnosis of obstructive sleep apnea in children in the home environment. | Definitive diagnosis of OSA and evaluation of sleep-related disorders in children. |
| How it is performed | Parents supervise and set up the portable device at home to record sleep data overnight. | Clinical staff attach sensors and continuously monitor the child overnight in a sleep laboratory. |
| Evidence status | Evidence for HSAT utility in children is limited and under active investigation. Existing position papers support research but do not recommend HSAT as an independent diagnostic standard in pediatric populations. | Established high-quality evidence supports PSG as the reference standard for diagnosing sleep apnea in children. Guidelines and management reviews consistently recommend PSG for pediatric OSA diagnosis. |
| Important limitations | HSAT may miss certain sleep-related events and has not been fully validated for pediatric OSA diagnosis. Technical failures and incomplete data are concerns in children due to movement, improper setup, or sensor detachment during the night. | PSG is resource-intensive, requires overnight laboratory stay, and may cause discomfort for children. Access can be limited by equipment, staffing, and the need for parental presence, and some children may find the sensors or environment distressing. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor