Sleep Apnea, Central, Sleep Apnea, Obstructive
Conditions
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
Interventions
DEVICEApneaLink Plus
Device used to evaluate for the presence of obstructive, central or mixed apneas
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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-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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PSG/ApneaLink Sleep Evaluation under Polysomnography and with ApneaLink | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Invalid measurement | 1 |
Baseline characteristics
| Characteristic | PSG/ApneaLink | — |
|---|---|---|
| Age, Continuous | 53.73 years STANDARD_DEVIATION 16.26 | — |
| Body Mass Index | 29.77 kg/m2 STANDARD_DEVIATION 4.23 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 22 participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
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
Time frame: one night
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PSG/ApneaLink | 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 | AHI_psg | 14.77 events/hour | Standard Deviation 14.97 |
| PSG/ApneaLink | 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 | AHI_al | 12.14 events/hour | Standard Deviation 12.04 |
p-value: 0.021Wilcoxon (Mann-Whitney)
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.
Time frame: 1 night
Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG/ApneaLink | Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL) | 0.968 correlation |
Comparison: Per recording, the number of events found per category with PSG and ApneaLink Plus will be compared. As a summary, all PSG values and all ApneaLink Plus values per category will be collected in one graph (Bland-Altmann Plot). The correlation coefficient will be calculated per category. A correlation of \>75% will be seen as threshold for validity.
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.
Time frame: 1 night
Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG/ApneaLink | Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL) | 0.935 Correlation |
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.
Time frame: 1 night
Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG/ApneaLink | Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL) | 0.754 Correlation |
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.
Time frame: 1 night
Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG/ApneaLink | Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL) | 0.939 Correlation |
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.
Time frame: 1 night
Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG/ApneaLink | Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL) | 0.852 Correlation |
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.
Time frame: 1 night
Population: Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG/ApneaLink | Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL) | 0.905 Correlation |