Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children

ResMed

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: ApneaLink Air

Study type: Interventional

Funder types: Industry

Identifiers

NCT03748771

UCSD 171173

Details and patient eligibility

About

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..

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ApneaLink Air

Experimental group

Description:

Half of the participants will undergo HST no greater than one week prior to their in-laboratory PSG, while the other half will undergo HST no greater than one week following their in laboratory PSG. All participants will also undergo their HST concurrent to their in-laboratory PSG. The rational for splitting participants in these two groups is to equally distribute the effects of the first night evenly, in which the sleep architecture including reduced total rapid eye movement (REM) sleep time can vary during the first ever sleep study. As the HST will be compared to the in-lab PSG, we would like to evenly distribute this effect by having two groups of ten participants.

Treatment:

Device: ApneaLink Air