Clinical trial NCT03473548: Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
Official title: Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Childhood OSA
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 11
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Greater Than or Equal to 6 Hours of Sleep Data
timeFrame: greater than or equal to 6 hours
Secondary outcomes:
measure: Apnea Hypopnea Index (AHI) Score
timeFrame: greater than or equal to 6 hours
measure: SPO2 Result
timeFrame: greater than or equal to 6 hours
measure: SPO2 Nadir
timeFrame: greater than or equal to 6 hours
measure: McGill Oximetry Score
timeFrame: greater than or equal to 6 hours
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: David Leonard, MD
role: PRINCIPAL_INVESTIGATOR
References: