St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
NCT Number: NCT03473548
The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography in pediatric patients.
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Notify Me5 year–12 year
All sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
The purpose of the study proposed is twofold. First Investigators will test the feasibility of conducting portable sleep monitoring in school aged children using the Clevemed Sleepview (www.clevelmed.com), one of the smallest portable sleep monitors commercially available at 57 grams. Second, Investigators will perform a direct comparison between the results obtained with this portable sleep monitor and those obtained from a standard-of-care in-laboratory attended sleep study performed at the St. Louis Children's Hospital Pediatric Sleep Center. These comparisons will be offered to the participants suspected of having sleep disordered breathing who present to the Washington University Pediatric Otolaryngology Department. Investigators will obtain the medical history and medications and results of the sleep study done at SLCH sleep lab from the medical record for research purposes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Type III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis
Polysomnography testing will determine the sleep stages, apnea hypopnea index (AHI), blood saturation oxygen nadir (SPO2 nadir), and average blood oxygen saturation. A McGill Oximetry Score will also be calculated for the in-laboratory PSG.
Time frame: greater than or equal to 6 hours
Feasibility of obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index using un-attended polysomnography; polysomnography analysis will be performed to determine if an apnea hypopnea index can be determined; <5=Normal (no Sleep Apnea); 5-15=Mild Sleep Apnea; 15-30=Moderate Sleep Apnea; >30 Severe Sleep Apnea
Time frame: greater than or equal to 6 hours
Number of participants with Apnea Hypopnea Index (AHI) score
Time frame: greater than or equal to 6 hours
Number of Participants with an SPO2 result
Time frame: greater than or equal to 6 hours
Number of participants with an SPO2 nadir
Time frame: greater than or equal to 6 hours
Number of participants with McGill Oximetry Score
Washington University School of Medicine
Other
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