Clinical trial NCT03748771: Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
Official title: Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of obstructive sleep apnea (OSA) in adults..

Detailed description: Obstructive sleep apnea is highly prevalent in children affecting 2-3% of children and up to 10% of obese children. The reported prevalence is likely underestimated due to the lack of available laboratory polysomnography (PSG) testing for children. The high prevalence of OSA coupled with an increase in obesity, a major risk factor of OSA in children, has resulted in a significant strain for in laboratory PSG including children in the greater San Diego county. Currently, HST in children is restricted based on the limited availability of HST devices on children that have attained clearance by the US Food and Drug Administration (FDA). In this study, the feasibility and the validity of the ApneaLink Air HST device will be tested in children 12 years old and over. The ApneaLink Air HST device is cleared for the diagnosis of OSA in adults and is frequently used amongst adult sleep medicine physicians. Adolescent children will be recruited whose clinically indicated in laboratory PSG will be performed at Rady Children's Hospital. Concurrent to their in-laboratory PSG, they will have their sleep assessed using the ApneaLink Air device. Ten children will repeat the ApneaLink Air HST at home following their sleep study within one week, and the remaining ten children will have their ApneaLink Air HST performed within one week prior to their in laboratory clinically indicated PSG.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with symptoms of OSA needing a sleep study
* Patients between the ages of 12 and 17 years, inclusive

Exclusion Criteria:

* Patients less than 12 years old
* Patients 18 years old or older
* Children with syndromes or congenital disease including Down Syndrome, Prader-Willi syndrome, children with craniofacial disorders, and finally children with congenital heart disease or pulmonary hypertension

Primary outcomes:
measure: Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
timeFrame: Day 1
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Day 1
measure: Number of Successful HST Evaluations
timeFrame: Day 1
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
References:
citation: Bhattacharjee R, Benjafield A, Blase A, Dever G, Celso J, Nation J, Good R, Malhotra A. The accuracy of a portable sleep monitor to diagnose obstructive sleep apnea in adolescent patients. J Clin Sleep Med. 2021 Jul 1;17(7):1379-1387. doi: 10.5664/jcsm.9202.