ApneaLink Air Home Sleep Testing (HST) Device Validation Study

Status Completed

Clinical Trial Summary

This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03470493
Study type	Interventional
Source	ResMed
Contact
Status	Completed
Phase	N/A
Start date	April 11, 2018
Completion date	July 31, 2019

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05547477` - Continuous EMG Measurements in Children With Asthma During Sleep
Completed	`NCT01503164` - Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism	N/A
Recruiting	`NCT00863421` - Sleep Disordered Breathing in Patients With Chronic Heart Failure	N/A
Completed	`NCT00841906` - Alice PDx User/Validation Extended Trial	N/A
Not yet recruiting	`NCT05462834` - Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing	N/A
Recruiting	`NCT01785199` - Effects of Head Elevation by a Bed on Sleep-disordered Breathing	Phase 1
Recruiting	`NCT06043830` - Managing Opioid Related Sleep Apnea With Acetazolamide	Phase 2
Recruiting	`NCT04351698` - SMILES: Study of Montelukast in Sickle Cell Disease	Phase 2/Phase 3
Active, not recruiting	`NCT05643352` - Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring	N/A
Recruiting	`NCT03142022` - Sleep-disordered Breathing After Solid Organ Transplantation
Recruiting	`NCT05336890` - Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Recruiting	`NCT05466864` - Screening of OSA in Hospitalized Stroke Patients Using BSP	N/A
Recruiting	`NCT05661747` - Dental Appliance to Treat SDB in Children	Phase 4
Completed	`NCT02855515` - Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea	N/A
Recruiting	`NCT05575401` - Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy	N/A
Completed	`NCT02923505` - Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)
Completed	`NCT06154577` - Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy
Recruiting	`NCT04331821` - READ-ASV Registry - Phase II
Completed	`NCT02830074` - Treatment of Sleep-disordered Breathing in Patients With SCI	N/A
Completed	`NCT02760680` - Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure	N/A