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

Recruiting

• Conditions: Sleep Apnea Syndromes
• Interventions: Other: Treatment

• Registration Number: NCT05795270
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-15
• Status Verified: 2023-03
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03
• Primary Completion: 2023-08-24
• Study Completion: 2023-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sleep apnea syndrome with excessive daytime sleepiness	Treatment	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Oggebbio, Italy