Evaluation of ApneaLink Plus Scoring Capabilities

ResMed

Status: Completed

Conditions: Sleep Apnea, Obstructive; Sleep Apnea, Central

Treatments: Device: ApneaLink Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00823134

D2231-109

Details and patient eligibility

About

The purpose of this study is to investigate the following topics:

• Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas, Mixed Apneas and Central Apneas.
• Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008 guidelines of the AASM = American Academy of Sleep Medcine.
• Determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet

Full description

• Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas, Mixed Apneas and Central Apneas.
• Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008 guidelines of the AASM = American Academy of Sleep Medcine.
• Determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to give written informed consent
• Adult patients who are 18 years of age or older
• No alcohol consumption 12 hrs before and during the trial period
• Normally sleep more than 3 hours per night

Exclusion criteria

• Unable to comprehend written and spoken German.
• Pregnant
• Patients who use of Bilevel PAP or CPAP therapy during the PSG
• Unsuitable for inclusion in the opinion of the investigator

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

AL + polysomnography

Other group

Description:

Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).

Treatment:

Device: ApneaLink Plus