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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea Syndromes
• Intervention / Treatment: Other: Treatment

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Riccardo Cremascoli, MD; Phone Number: +393497292068; Email: r.cremascoli@auxologico.it

Study Locations

• Italy
  • Oggebbio, Italy
    • Recruiting
    • Istituto Auxologico Italiano
    • Contact: Riccardo Cremascoli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with sleep apnea syndrome with excessive daytime sleepiness

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sleep apnea syndrome with excessive daytime sleepiness	Other: Treatment; Nocturnal ventilotherapy, positional therapy and oro-mandibular devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of light chain neurofilaments	Plasma level of light chain neurofilaments (NFL)	At baseline and after 3 months of treatment
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
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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Anticipated): August 24, 2023
• Study Completion (Anticipated): August 24, 2023

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hypersomnia; Excessive daytime sleepiness; Neurodegeneration biomarkers
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea; Nerve Degeneration; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: 21C121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No