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

NCT03473548 | Completed Results DMC FDA Device

• 1 other identifier: 201710103
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Childhood OSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Apnea Hypopnea Index (AHI) Score

  greater than or equal to 6 hours

• SPO2 Result

  greater than or equal to 6 hours

• SPO2 Nadir

  greater than or equal to 6 hours

• McGill Oximetry Score

  greater than or equal to 6 hours

Study Arms (2)

Unmonitored Polysomnography

EXPERIMENTAL

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

In-laboratory Polysomnography

ACTIVE COMPARATOR

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

Interventions

Portable sleep monitor DEVICE

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

Unmonitored Polysomnography

In-laboratory Polysomnography OTHER

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.

In-laboratory Polysomnography

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. David Leonard
• Organization: Washington University

dsleonard@wustl.edu

314-454-6162

Study Officials

• David Leonard, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 22, 2018
• Study Start: December 28, 2017
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-01

Locations

US (1)