An observational study in Sleep Apnea Syndromes, sponsored by Istituto Auxologico Italiano. Status unknown at 1 site in Italy. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by Istituto Auxologico Italiano · Observational
Excessive daytime sleepiness which still remains after an effective treatment with nocturnal ventilotherapy or with other specific treatments (positional therapy, oro-mandibular devices) in patients with obstructive sleep apnea syndrome has a prevalence of 55% of treated cases, representing a notable theme of clinical and research interest.
In recent years there have been several studies on the use of wakefulness-promoting drugs generally prescribed in patients with narcolepsy, in this disorder with promising results. Right in consideration of the forthcoming approval of these drugs, it is important to find biomarkers able to predict which patients will develop daytime sleepiness resistant to ventilatory treatment. Several studies have highlighted the association between obstructive sleep apnea syndrome and the increase of cerebral amyloid beta deposits, concluding that apnoic disorder can be considered a risk factor for the development of cognitive impairment and Alzheimer';s disease.
In this scenario, it would be useful to identify biological markers able to underline which clinical phenotypes of sleep apnea syndrome are more associated with residual excessive daytime sleepiness and/or cognitive impairment. In recent years several kits for the assay of biomarkers of neurodegeneration have been developed not only in CSF, but also in human serum. Among them, the most important are light chain neurofilaments (NFL), amyloid isoforms 40 and 42 (Ab40 and Ab42). Other biomarkers found in neurodegenerative diseases associated with excessive daytime sleepiness are orexin A (OXA) and histamine (HA).
In this view, the aim of this study is to evaluate the role of biomarkers of neurodegeneration in characterizing disease severity and response to treatment of obstructive sleep apnea syndrome with residual excessive daytime sleepiness.
2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.
This study's planned enrollment of 100 is close to the median of 109 across 659 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 78 are open to participants now.
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Patients with sleep apnea syndrome with excessive daytime sleepiness
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Exclusion Criteria:
Other: Treatment
Nocturnal ventilotherapy, positional therapy and oro-mandibular devices
Change in level of light chain neurofilaments
Plasma level of light chain neurofilaments (NFL)
Time frame: At baseline and after 3 months of treatment
Change in level of amyloid isoforms 40 and 42
Plasma level of amyloid isoforms 40 and 42 (Ab40 and Ab42)
Time frame: At baseline and after 3 months of treatment
Change in level of daytime sleepiness - Epworth Sleepiness scale
Level daytime sleepiness - Epworth Sleepiness scale - Minimum 0, Maximum 24
Time frame: At baseline and after 3 months of treatment
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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