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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473548
• Other study ID #: 201710103
• Status: Completed
• Phase: N/A
• Start date: December 28, 2017
• Est. completion date: October 14, 2019

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

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

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.

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Apnea Hypopnea Index (AHI) Score	Number of participants with Apnea Hypopnea Index (AHI) score	greater than or equal to 6 hours
Secondary	SPO2 Result	Number of Participants with an SPO2 result	greater than or equal to 6 hours
Secondary	SPO2 Nadir	Number of participants with an SPO2 nadir	greater than or equal to 6 hours
Secondary	McGill Oximetry Score	Number of participants with McGill Oximetry Score	greater than or equal to 6 hours