Sleep Apnea SyndromesEDS in OSANCT05795270
Multicenter Study on the Role of Neurodegeneration Biomarkers in Obstructive Sleep Apnea Syndrome With Residual Excessive Daytime Sleepiness.
An observational study of Sleep Apnea Syndromes, run by Istituto Auxologico Italiano at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2020to 24 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sleep apnea syndrome with excessive daytime sleepiness
Who may be able to join
- Mild or moderate-severe obstructive sleep apnea
- Written informed consent
Who cannot join
- Other sleep disorders
- Pregnancy or breastfeeding
- Cerebral diseases or neuropsychiatric deficits
- Psychiatric disorders
- Impossibility to provide informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Oggebbio
Riccardo Cremascoli, MD
About this study
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.
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.
Read more
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
- Being tested
- Treatment
- Keywords
- Hypersomnia, Excessive daytime sleepiness, Neurodegeneration biomarkers
- Medical subject headings
- Sleep Apnea Syndromes, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Nocturnal ventilotherapy, positional therapy and oro-mandibular devices
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea syndrome with excessive daytime sleepiness | Not described Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of light chain neurofilaments
Plasma level of light chain neurofilaments (NFL)
Measured: 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)
Measured: 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
Measured: At baseline and after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start15 Dec 2020
- Primary completion24 Aug 2023 (estimated)
- Study completion24 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795270
- Sponsor's protocol ID
- 21C121
- Acronym
- EDS in OSA
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05795270
- Acronym / sponsor ID
- EDS in OSA / 21C121
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Hypersomnia, Excessive daytime sleepiness, Neurodegeneration biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 24 Aug 2023 (estimated)
- Study completion
- 24 Aug 2023 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea syndrome with excessive daytime sleepiness | – | Other: Treatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sleep apnea syndrome with excessive daytime sleepiness
Key inclusion criteria (2 listed)
- Mild or moderate-severe obstructive sleep apnea
- Written informed consent
Key exclusion criteria (5 listed)
- Other sleep disorders
- Pregnancy or breastfeeding
- Cerebral diseases or neuropsychiatric deficits
- Psychiatric disorders
- Impossibility to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentNocturnal ventilotherapy, positional therapy and oro-mandibular devices | Other | Sleep apnea syndrome with excessive daytime sleepiness |
Primary outcome
Change in level of light chain neurofilaments
Time frame: At baseline and after 3 months of treatment
Plasma level of light chain neurofilaments (NFL)
Change in level of amyloid isoforms 40 and 42
Time frame: 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
Time frame: At baseline and after 3 months of treatment
Level daytime sleepiness - Epworth Sleepiness scale - Minimum 0, Maximum 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Cremascoli, MD (+393497292068, r.cremascoli@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of light chain neurofilaments (time frame: At baseline and after 3 months of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.