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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Portable sleep monitor; Other: In-laboratory Polysomnography

• Registration Number: NCT03473548
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study Start: 2017-12-28
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-22
• Primary Completion: 2019-10-14
• Study Completion: 2019-10-14
• Results First Submitted: 2021-06-09
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Results First Posted: 2024-02-07
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• 5- to 12-years-old
• Parental informed consent
• Suspected Sleep Disordered Breathing

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unmonitored Polysomnography	Portable sleep monitor	All eligible subjects will be asked to conduct an unattended, overnight sleep study performed in their home prior to in-laboratory polysomnography, using a standard Type III portable monitor. The type III portable sleep monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
In-laboratory Polysomnography	In-laboratory Polysomnography	All eligible subjects will have in-laboratory polysomnography as is routinely performed in the diagnostic work up for suspected sleep disordered breathing.

Primary Outcome Measures

Name	Time	Method
Greater Than or Equal to 6 Hours of Sleep Data	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

Secondary Outcome Measures

Name	Time	Method
SPO2 Nadir	greater than or equal to 6 hours	Number of participants with an SPO2 nadir
SPO2 Result	greater than or equal to 6 hours	Number of Participants with an SPO2 result
McGill Oximetry Score	greater than or equal to 6 hours	Number of participants with McGill Oximetry Score
Apnea Hypopnea Index (AHI) Score	greater than or equal to 6 hours	Number of participants with Apnea Hypopnea Index (AHI) score

Trial Locations

Locations (1)

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States