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

Sleep Apnea Syndromes Clinical Trial

— EDS in OSA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795270
• Other study ID #: 21C121
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Apnea
• Disorders of Excessive Somnolence
• Nerve Degeneration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleepiness
• Syndrome

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