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Orexin B 2020-12-15 ClinicalTrials

Neurodegeneration Biomarkers to Predict Residual Daytime Sleepiness in Obstructive Sleep Apnea Patients

Multicenter Study on the Role of Neurodegeneration Biomarkers in Obstructive Sleep Apnea Syndrome With Residual Excessive Daytime Sleepiness.

Background

Residual excessive daytime sleepiness (EDS) affects up to 55% of patients with Obstructive Sleep Apnea Syndrome (OSAS) despite effective ventilatory treatment, posing a significant clinical challenge. Current wakefulness-promoting drugs show promise, but identifying patients who will benefit remains difficult. Previous research links OSAS to increased cerebral amyloid beta deposits, suggesting it's a risk factor for cognitive impairment and Alzheimer's disease. There's a critical need for biological markers to predict which OSAS phenotypes are associated with persistent EDS and/or cognitive decline, guiding personalized treatment strategies.

Study Design

This multicenter study, with an estimated enrollment of 65 patients, aims to evaluate the role of specific neurodegeneration biomarkers in characterizing disease severity and treatment response in OSAS patients with residual EDS. Researchers plan to assay light chain neurofilaments (NFL), amyloid isoforms 40 (Ab40) and 42 (Ab42), orexin A (OXA), and histamine (HA). These biomarkers will be measured in human serum, leveraging recently developed assay kits. The study will assess how these markers correlate with clinical phenotypes of OSAS and their association with residual excessive daytime sleepiness and/or cognitive impairment before and after ventilotherapy.

Why It Matters

Identifying reliable neurodegeneration biomarkers for Obstructive Sleep Apnea Syndrome (OSAS) could revolutionize how residual excessive daytime sleepiness (EDS) is managed. This research could enable clinicians to predict which OSAS patients will develop persistent EDS or cognitive impairment, allowing for earlier, more targeted interventions. Instead of a trial-and-error approach, future protocols might incorporate biomarker screening to guide the use of wakefulness-promoting drugs or other therapies. This could lead to personalized treatment strategies, improving patient outcomes and potentially mitigating long-term neurological risks associated with OSAS, moving beyond current symptomatic management to a more predictive and preventative model.


obstructive-sleep-apnea excessive-daytime-sleepiness neurodegeneration biomarkers amyloid-beta orexin
Source: clinicaltrials:NCT05795270 · Ingested 2026-06-12 · Digest: gemini-2.5-flash