Clinical trial NCT05795270: Multicenter Study on the Role of Neurodegeneration Biomarkers in Obstructive Sleep Apnea Syndrome With Residual Excessive Daytime Sleepiness.
Official title: Multicenter Study on the Role of Neurodegeneration Biomarkers in Characterizing the Severity of Disease and Response to Therapeutic Treatment of Patients With Obstructive Sleep Apnea Syndrome With Residual Excessive Daytime Sleepiness.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndromes
Keywords: Hypersomnia
Excessive daytime sleepiness
Neurodegeneration biomarkers
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sleep apnea syndrome with excessive daytime sleepiness

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in level of light chain neurofilaments
timeFrame: At baseline and after 3 months of treatment
measure: Change in level of amyloid isoforms 40 and 42
timeFrame: At baseline and after 3 months of treatment
measure: Change in level of daytime sleepiness - Epworth Sleepiness scale
timeFrame: At baseline and after 3 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References: