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The purpose of this study is to investigate the following topics:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL + polysomnography | Other | Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ApneaLink Plus | Device | Device used to evaluate for the presence of obstructive, central or mixed apneas |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knut Joechle, PhD | ResMed | Study Director |
| Heribert Knape, MD | Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen | Wangen | Baden-Wurttemberg | 88239 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | PSG/ApneaLink | Sleep Evaluation under Polysomnography and with ApneaLink |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | PSG/ApneaLink | Sleep Evaluation under Polysomnography and with ApneaLink |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | events/hour | one night |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PSG/ApneaLink | Sleep Evaluation under Polysomnography and with ApneaLink |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oliver Munt | ResMed Germany Inc | 0899901 | 00 | oliver.munt@resmed.de |
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| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Participants |
|
|
|
| Primary | 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. | Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded. | Posted | Number | correlation | 1 night |
|
|
|
|
| Primary | 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. | Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded. | Posted | Number | Correlation | 1 night |
|
|
|
| Primary | 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. | Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded. | Posted | Number | Correlation | 1 night |
|
|
|
| Primary | 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. | Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded. | Posted | Number | Correlation | 1 night |
|
|
|
| Primary | 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. | Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded. | Posted | Number | Correlation | 1 night |
|
|
|
| Primary | 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. | Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded. | Posted | Number | Correlation | 1 night |
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|
| 0 |
| 22 |
| 0 |
| 22 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |