ApneaLink Air Home Sleep Testing (HST) Device Validation Study
Status: | Active, not recruiting |
---|---|
Conditions: | Insomnia Sleep Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/29/2019 |
Start Date: | April 11, 2018 |
End Date: | June 2019 |
Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography
This study compares the diagnostic capability of a home sleep apnea testing device to
polysomnography.
polysomnography.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
2
sites
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Richard Berry, MD
Phone: 352-273-5870
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Alexandre Abreu, MD
Phone: 305-243-2568
University of Miami A private research university with more than 15,000 students from around the...
Click here to add this to my saved trials