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

Primary Purpose

Sleep Apnea, Obstructive

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portable sleep monitor
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Apnea, Obstructive focused on measuring Childhood OSA

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • St. Louis Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Portable Sleep Monitor

Arm Description

Type III portable 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of AHI
Compare apnea hypopnea index (AHI) between unmonitored polysomnography and in-laboratory polysomnography
Comparison of average SPO2
Compare average SPO2 between unmonitored polysomnography and in-laboratory polysomnography
Comparison of average SPO2 nadir
Compare average SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography
Comparison of the McGill Oximetry Score
Comparison of the McGill Oximetry Score between unattended and inpatient polysomnography.

Full Information

First Posted
March 13, 2018
Last Updated
May 12, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03473548
Brief Title
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
Official Title
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2017 (Actual)
Primary Completion Date
October 14, 2019 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Childhood OSA

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Portable Sleep Monitor
Arm Type
Experimental
Arm Description
Type III portable 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.
Intervention Type
Device
Intervention Name(s)
Portable sleep monitor
Intervention Description
Type III portable 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.
Primary Outcome Measure Information:
Title
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
Description
polysomnography analysis will be performed to determine if an apnea hypopnea index can be determined
Time Frame
greater than or equal to 6 hours
Secondary Outcome Measure Information:
Title
Comparison of AHI
Description
Compare apnea hypopnea index (AHI) between unmonitored polysomnography and in-laboratory polysomnography
Time Frame
greater than or equal to 6 hours
Title
Comparison of average SPO2
Description
Compare average SPO2 between unmonitored polysomnography and in-laboratory polysomnography
Time Frame
greater than or equal to 6 hours
Title
Comparison of average SPO2 nadir
Description
Compare average SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography
Time Frame
greater than or equal to 6 hours
Title
Comparison of the McGill Oximetry Score
Description
Comparison of the McGill Oximetry Score between unattended and inpatient polysomnography.
Time Frame
greater than or equal to 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Leonard, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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

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