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

NCT ID: NCT03473548

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-28
• Study Completion Date: 2019-10-14

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Portable sleep monitor

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

In-laboratory Polysomnography

Intervention Type: 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.

Interventions

Portable sleep monitor

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Leonard, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

St. Louis Children's Hospital

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

201710103

Identifier Type: -

Identifier Source: org_study_id