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Item response theory analysis of daytime sleepiness as a symptom of obstructive sleep apnea

Authors :
Gustaf J. Wellhagen
Mats O. Karlsson
Maria C. Kjellsson
Dirk Garmann
Astrid Bröker
Yang Zhang
Mika Nokela
Gerrit Weimann
Ashraf Yassen
Source :
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 5, Pp 880-890 (2024)
Publication Year :
2024
Publisher :
Wiley, 2024.

Abstract

Abstract Obstructive sleep apnea (OSA) is a sleep disorder which is linked to many health risks. The gold standard to evaluate OSA in clinical trials is the Apnea‐Hypopnea Index (AHI). However, it is time‐consuming, costly, and disregards aspects such as quality of life. Therefore, it is of interest to use patient‐reported outcomes like the Epworth Sleepiness Scale (ESS), which measures daytime sleepiness, as surrogate end points. We investigate the link between AHI and ESS, via item response theory (IRT) modeling. Through the developed IRT model it was identified that AHI and ESS are not correlated to any high degree and probably not measuring the same sleepiness construct. No covariate relationships of clinical relevance were found. This suggests that ESS is a poor choice as an end point for clinical development if treatment is targeted at improving AHI, and especially so in a mild OSA patient group.

Subjects

Subjects :
Therapeutics. Pharmacology
RM1-950

Details

Language :
English
ISSN :
21638306
Volume :
13
Issue :
5
Database :
Directory of Open Access Journals
Journal :
CPT: Pharmacometrics & Systems Pharmacology
Publication Type :
Academic Journal
Accession number :
edsdoj.993b6e91571c4c6f8e3e4f8438d40464
Document Type :
article
Full Text :
https://doi.org/10.1002/psp4.13125