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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: Portable sleep monitor; Other: In-laboratory Polysomnography

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unmonitored Polysomnography; 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.	Device: Portable sleep monitor; Type III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	greater than or equal to 6 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: David Leonard, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2017
• Primary Completion (Actual): October 14, 2019
• Study Completion (Actual): October 14, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Childhood OSA
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 201710103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes