ApneaLink Air Home Sleep Testing (HST) Device Validation Study
- Conditions
- Sleep-disordered Breathing
- Interventions
- Diagnostic Test: ApneaLink Air
- Registration Number
- NCT03470493
- Lead Sponsor
- ResMed
- Brief Summary
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
- Detailed Description
The current gold standard for sleep disordered breathing (SDB) diagnosis is in-laboratory polysomnography (PSG). A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their inability to accurately measure total sleep time (TST). A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately calculate TST, however, this algorithm has not yet been validated.
The ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four channels of data including: flow and snore via a nasal cannula attached to a pressure transducer, a respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy monitor to measure TST along with flow. The AL device has been validated against PSG for AHI, and Cheyne-Stoke respiration detection . Further validation of the effort belt is necessary to determine the accuracy of the AL ability to differentiate between obstructive and central apneic events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- Participant is 18 years of age or older
- Participant is willing to provide informed consent
- Participant is willing to participate in all study related procedures
- Unable to cease positive airway pressure (PAP) therapy during PSG (if currently using)
- Requires use of oxygen therapy during sleep
- Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless leg syndrome)
- Pregnant
- Participant is unsuitable to participate in the study in the opinion of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants ApneaLink Air ApneaLink Air
- Primary Outcome Measures
Name Time Method Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) Day 1 The Respiratory Event Index (REI) provided by the AL will be compared with the REI provided by the PSG test. REI will be scored according to American Academy of Sleep Medicine (AASM) 2012 guidelines.
The REI provided by the AL for each participant is divided by the REI provided by the PSG for the same participant to get the diagnostic sensitivity of the Apnealink.
- Secondary Outcome Measures
Name Time Method Positive Likelihood Ratio of Apnealink Air Day 1 The positive likelihood ratio (the estimated sensitivity divided by 1 minus the estimated specificity) was calculated along with the associated one-sided 97.5% confidence interval. The positive likelihood ratio was compared with the threshold of 5 (AASM criteria for out-of-center testing devices12) using a Wald test.
Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG Day 1 Total number of Central events reported by the ApneaLink (AL) compared with total number of Central Events reported by polysomnography (PSG). The Central events of the AL are divided by the Central events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825
Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events Day 1 Total number of Obstructive events reported by the ApneaLink (AL) compared with total number of Obstructive Events reported by polysomnography (PSG). The Obstructive events of the AL are divided by the Obstructive events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825
Trial Locations
- Locations (2)
University of Miami
🇺🇸Miami, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States