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

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..

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: ApneaLink Air

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.

• Study Type: Interventional
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Rady Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ApneaLink Air; 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.

Device: ApneaLink Air; The ApneaLink Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)	Accuracy is measured by ODI (oxygen desaturation index) and AHI (apnea hypopnea index) The ODI is defined as the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. The ODI is presented as an index to indicate the number of oxygen dips per hour of sleep. The AHI indicates the number of apneas or hypopneas which occured during the sleep study, divided by the hours of sleep. The AHI is an Index which indicates how many events occurred each hour	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: "Do you prefer HST over PSG?"	Day 1
Number of Successful HST Evaluations	An unsuccesful HST or HST failure will be defined as: Loss of the nasal flow channel, or thoracic or abdominal sensor; Recordings with less than 4h of artifact-free recording time; Less than 4h of Sp02 signal	Day 1

Collaborators and Investigators

• Sponsor: ResMed

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: October 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: UCSD 171173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No