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

Washington University School of Medicine11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Sleep Apnea, Obstructive

Interventions

Portable sleep monitorDEVICE

Type III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis

In-laboratory PolysomnographyOTHER

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 5- to 12-years-old * Parental informed consent * Suspected Sleep Disordered Breathing Exclusion Criteria: * Developmental delay * Use of home oxygen * History of Parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism) * History of tracheal surgery * History of tracheal stenosis * History of Nocturnal Hypoventilation * History of Central Sleep Apnea * Use of a Ventilatory Assist Device (e.g. Non-Invasive Positive Pressure Ventilation)

Locations (1)

St. Louis Children's Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Greater Than or Equal to 6 Hours of Sleep Data

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