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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748771
• Other study ID #: UCSD 171173
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: October 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Satisfaction	Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: "Do you prefer HST over PSG?"	Day 1
Secondary	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