N/A
Completed N=23
Evaluation of ApneaLink Plus Scoring Capabilities
Sleep Apnea, Central · Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT00823134 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: 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 — 14.77; 12.14 events/hour — p=0.021
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
14.77; 12.14 | 0.021 sig |
| PRIMARY Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL) |
0.968 | — |
| PRIMARY Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL) |
0.935 | — |
| PRIMARY Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL) |
0.852 | — |
| PRIMARY Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL) |
0.939 | — |
| PRIMARY Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL) |
0.754 | — |
| PRIMARY Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL) |
0.905 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00823134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.