NCT03473548

Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	Portable sleep monitor	Type III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis
OTHER	In-laboratory Polysomnography	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.

Timeline

• Start date: 2017-12-28
• Primary completion: 2019-10-14
• Completion: 2019-10-14
• First posted: 2018-03-22
• Last updated: 2024-02-07
• Results posted: 2024-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study