Evaluation of ApneaLink Plus Scoring Capabilities
- Conditions
- Sleep Apnea, ObstructiveSleep Apnea, Central
- Registration Number
- NCT00823134
- Lead Sponsor
- ResMed
- Brief Summary
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
* 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 one night 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
Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL) 1 night 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.
Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL) 1 night 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.
Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL) 1 night 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.
Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL) 1 night 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.
Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL) 1 night 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.
Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL) 1 night 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen
🇩🇪Wangen Im Allgäu, Baden-Württemberg, Germany
Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen🇩🇪Wangen Im Allgäu, Baden-Württemberg, Germany