G47.31
Conditions
Interventions
Group 1: Study participants will be recruited as part of clinical routine during the duration of the study. Patients with suspected or confirmed OSA who are to undergo polysomnography and drug-induced
Sponsors
Sektion für Schlafmedizin, Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie, Medizinische Fakultät Mannheim der Ruprecht Karls-Universität Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: - >18 years of age - Diagnosed OSA with a history of snoring - Indication for polysomnography and DISE examination for further therapy recommendation
Exclusion criteria
Exclusion criteria: - <18 years - Lack of willingness or contraindication for conducting a MISE - Lack of willingness to participate in the study - Insomnia - Hypersomnia - Parasomnia - Acute infection - Shift work during the study period - Other conditions or behaviors that, at the discretion of the study physicians, preclude participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Since the main objective is to achieve consistency between DISE (according to VOTE), which does not correspond to natural sleep, and acoustic phenotyping (according to ACLTE) in natural sleep in the same patients over three nights, the target values should be measurable consistency values: 1) Kappa coefficient for classification consistency • Measures the consistency between MISE results (VOTE) and acoustic phenotyping (ACLTE) 1) Kappa coefficient for classification agreement • Measures the agreement between MISE results (VOTE) and acoustic phenotyping (ACLTE) in natural sleep over 3 nights. • Value range: 0 (no agreement) to 1 (perfect agreement). • Separate calculation for vibration types and obstruction types. 2) Percentage agreement (%) between DISE (VOTE) and ACLTE and kappa coefficient • Proportion of patients for whom the classifications agree. • Calculation for overall agreement and depending on body position (side/back position). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints For the secondary endpoints relating to interrater agreement and correlations between snoring and obstruction events: 1) Correlation between snoring types and obstruction types (kappa correlation coefficient) • Analysis of whether certain snoring types according to VOTE are associated with specific obstruction types according to VOTE. • Separate consideration for the total population depending on body position. 2) Night-to-night variability of patients in natural sleep • Analysis of whether certain types of snoring according to VOTE are associated with specific variability. • Separate consideration for the total population depending on body position. | — |
Countries
Germany
Contacts
Public ContactJoachim Maurer
Sektion für Schlafmedizin, Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie, Medizinische Fakultät Mannheim der Ruprecht Karls-Universität Heidelberg
Outcome results
None listed