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Completed

NCT Number: NCT00823134

Evaluation of ApneaLink Plus Scoring Capabilities

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

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Key information

Conditions

Sleep Apnea, Central Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen

Wangen, Baden-Wurttemberg, 88239, Germany

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ApneaLink Plus

Device

Device used to evaluate for the presence of obstructive, central or mixed apneas

Other names: AL Plus

Primary outcomes

  1. 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

    Time frame: 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

  2. Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)

    Time frame: 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.

  3. Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)

    Time frame: 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.

  4. Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)

    Time frame: 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.

  5. Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)

    Time frame: 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.

  6. Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)

    Time frame: 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.

  7. Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 15, 2009
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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