Evaluation of ApneaLink Plus Scoring Capabilities

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Evaluation of ApneaLink Plus Scoring Capabilities

Conditions
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Sleep Apnea, Central, Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: ApneaLink Plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AL + polysomnography<br>Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central). | Device: ApneaLink Plus<br>* Device used to evaluate for the presence of obstructive, central or mixed apneas<br>* Other names: AL Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Apnoea-Hypopnea-Index (Number of Apneas (All Apneas, Obstructive, Mixed, Central) and Number of Hypopneas) Between ApneaLink Plus and a PSG System Within the Same Evaluation Period | Apnoea is defined as a decrease in flow of ≥90% from baseline for at least 10 seconds; hypopnea is a decrease in flow ≥30% from baseline for at least 10 seconds and an oxygen desaturation of ≥4%; obstructive: breathing efforts are ongoing; central: no breathing efforts | one night | 
| Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL) | The AHI (PSG) values and AHI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity. | 1 night | 
| Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL) | The AI (PSG) values and AI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity. | 1 night | 
| Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL) | The OAI (PSG) values and OAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity. | 1 night | 
| Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL) | The CAI (PSG) values and CAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity. | 1 night | 
| Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL) | The HI (PSG) values and HI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity. | 1 night | 
| Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL) | The ODI (PSG) values and ODI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of >75% will be seen as threshold for validity. | 1 night |