Sleep Apnea Syndromes
Conditions
Keywords
Hypersomnia, Excessive daytime sleepiness, Neurodegeneration biomarkers
Brief summary
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.
Interventions
OTHERTreatment
Nocturnal ventilotherapy, positional therapy and oro-mandibular devices
Sponsors
Istituto Auxologico Italiano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Mild or moderate-severe obstructive sleep apnea * Written informed consent
Exclusion criteria
* Other sleep disorders * Pregnancy or breastfeeding * Cerebral diseases or neuropsychiatric deficits * Psychiatric disorders * Impossibility to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in level of light chain neurofilaments | At baseline and after 3 months of treatment | Plasma level of light chain neurofilaments (NFL) |
| Change in level of amyloid isoforms 40 and 42 | At baseline and after 3 months of treatment | Plasma level of amyloid isoforms 40 and 42 (Ab40 and Ab42) |
| Change in level of daytime sleepiness - Epworth Sleepiness scale | At baseline and after 3 months of treatment | Level daytime sleepiness - Epworth Sleepiness scale - Minimum 0, Maximum 24 |
Countries
Italy
Contacts
Primary ContactRiccardo Cremascoli, MD
Outcome results
None listed