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

The Washington University

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Other: In-laboratory Polysomnography; Device: Portable sleep monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03473548

201710103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Unmonitored Polysomnography

Experimental group

Description:

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.

Treatment:

Device: Portable sleep monitor

In-laboratory Polysomnography

Active Comparator group

Description:

All eligible subjects will have in-laboratory polysomnography as is routinely performed in the diagnostic work up for suspected sleep disordered breathing.

Treatment:

Other: In-laboratory Polysomnography