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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05795270
Other study ID # 21C121
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2020
Est. completion date August 24, 2023

Study information

Verified date March 2023
Source Istituto Auxologico Italiano
Contact Riccardo Cremascoli, MD
Phone +393497292068
Email r.cremascoli@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 24, 2023
Est. primary completion date August 24, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Treatment
Nocturnal ventilotherapy, positional therapy and oro-mandibular devices

Locations

Country Name City State
Italy Istituto Auxologico Italiano Oggebbio

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in level of light chain neurofilaments Plasma level of light chain neurofilaments (NFL) At baseline and after 3 months of treatment
Primary Change in level of amyloid isoforms 40 and 42 Plasma level of amyloid isoforms 40 and 42 (Ab40 and Ab42) At baseline and after 3 months of treatment
Primary Change in level of daytime sleepiness - Epworth Sleepiness scale Level daytime sleepiness - Epworth Sleepiness scale - Minimum 0, Maximum 24 At baseline and after 3 months of treatment
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