Status:

COMPLETED

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

Lead Sponsor:

Washington University School of Medicine

Conditions:

Sleep Apnea, Obstructive

Eligibility:

All Genders

5-12 years

Phase:

NA

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 ...

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....

Eligibility Criteria

Inclusion

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

Exclusion

  • 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)

Key Trial Info

Start Date :

December 28 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 14 2019

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT03473548

Start Date

December 28 2017

End Date

October 14 2019

Last Update

February 7 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

St. Louis Children's Hospital

St Louis, Missouri, United States, 63110