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

NCT05795270 | Unknown

• 1 other identifier: 21C121
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes

Keywords

Hypersomnia; Excessive daytime sleepiness; Neurodegeneration biomarkers

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Sleep apnea syndrome with excessive daytime sleepiness

Other: Treatment

Interventions

Treatment OTHER

Nocturnal ventilotherapy, positional therapy and oro-mandibular devices

Sleep apnea syndrome with excessive daytime sleepiness

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sleep apnea syndrome with excessive daytime sleepiness

You may qualify if:

• Mild or moderate-severe obstructive sleep apnea
• Written informed consent

You may not qualify if:

• Other sleep disorders
• Pregnancy or breastfeeding
• Cerebral diseases or neuropsychiatric deficits
• Psychiatric disorders
• Impossibility to provide informed consent

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Oggebbio, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Sleep Apnea Syndromes; Disorders of Excessive Somnolence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Riccardo Cremascoli, MD

CONTACT

+393497292068; r.cremascoli@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: December 15, 2020
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

IT (1)