Obstructive Sleep Apnoea SyndromeNCT02043483
Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome
An observational study of Obstructive Sleep Apnoea Syndrome, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular markers for this physiopathological connection have been identified. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Obstructive Sleep Apnoea Syndrome
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2012to Dec 2014
- 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 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Obstructive Sleep Apnoea Syndrome Males 25-60 years
Who may be able to join
- Male
- 25-60 years
- Mild/Moderate/Severe OSAS
Who cannot join
- Female
- Other sleep disorders
- Previous CPAP therapy
- Type 1 diabetes mellitus
- Familiar Dyslipidemia
- Severe organ pathology
- Acute disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstructive Sleep Apnoea and Associated Metabolic/Cardiovascular Disorders: Understanding Mechanisms Towards Early Diagnosis and Prognosis
Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular markers for this physiopathological connection have been identified.
This project aims to determine non-invasive biomarkers that may allow better comprehension of the metabolic consequences of OSAS, as well as assess the effect of Continuous positive airway pressure (CPAP) on these metabolic parameters.
This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems to further explore the mechanisms behind OSAS, as well as the effect of the treatment with CPAP.
- Conditions
- Obstructive Sleep Apnoea Syndrome
- Keywords
- CPAP, OSAS, CEDOC (Centro de Estudos de Doenças Crónicas), FCM (Faculdade de Ciências Médicas), UNL (Universidade Nova de Lisboa, NOVA MEDICAL SCHOOL, FCT (Fundação para a Ciência e Tecnologia)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Patients with moderate/severe OSAS will be treated with CPAP | |
| Control | Patients with snoring will not be subject to treatment with CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical improvement
Treatment efficacy of CPAP will be assessed at the end of treatment through a clinical observation.
Measured: 6 months
Secondary outcomes (1)
Frequency of occurence of biomarkers
Using Mass Spectrometric Immunoassay, we will identify which biomarkers have a positive association with long-term treatment effect.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnoea SyndromeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Estudos de Doenças Crónicas, NOVA Medical School, Centro Hospitalar Lisboa Norte, National Health Institute Dr. Ricardo Jorge, Biotempo, Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
- Investigators
- Amélia Feliciano, MD, Principal investigator, Centro Hospitalar Lisboa Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043483
- Sponsor's protocol ID
- FCM-
- Status last verified
- Feb 2015
- First submitted
- 12 Nov 2013
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnoea and Associated Metabolic/Cardiovascular Disorders: Understanding Mechanisms Towards Early Diagnosis and Prognosis
- ClinicalTrials.gov ID
- NCT02043483
- Acronym / sponsor ID
- FCM-
- Conditions
- Obstructive Sleep Apnoea Syndrome
- Keywords
- CPAP, OSAS, CEDOC (Centro de Estudos de Doenças Crónicas), FCM (Faculdade de Ciências Médicas), UNL (Universidade Nova de Lisboa, NOVA MEDICAL SCHOOL, FCT (Fundação para a Ciência e Tecnologia)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Centro de Estudos de Doenças Crónicas, NOVA Medical School, Centro Hospitalar Lisboa Norte, National Health Institute Dr. Ricardo Jorge, Biotempo, Fundação para a Ciência e a Tecnologia
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Jan 2014 (estimated)
- 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.
Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular markers for this physiopathological connection have been identified.
This project aims to determine non-invasive biomarkers that may allow better comprehension of the metabolic consequences of OSAS, as well as assess the effect of Continuous positive airway pressure (CPAP) on these metabolic parameters.
This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems to further explore the mechanisms behind OSAS, as well as the effect of the treatment with CPAP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | – | –Patients with moderate/severe OSAS will be treated with CPAP |
| Control | – | –Patients with snoring will not be subject to treatment with CPAP |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Obstructive Sleep Apnoea Syndrome Males 25-60 years
Key inclusion criteria (3 listed)
- Male
- 25-60 years
- Mild/Moderate/Severe OSAS
Key exclusion criteria (7 listed)
- Female
- Other sleep disorders
- Previous CPAP therapy
- Type 1 diabetes mellitus
- Familiar Dyslipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with clinical improvement
Time frame: 6 months
Treatment efficacy of CPAP will be assessed at the end of treatment through a clinical observation.
1 secondary outcome
Frequency of occurence of biomarkers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
Related trials for Obstructive Sleep Apnoea Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Amélia Feliciano, MD principal investigator
Centro Hospitalar Lisboa Norte
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 Obstructive Sleep Apnoea Syndrome, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 18 Feb 2015. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with clinical improvement (time frame: 6 months). 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 18 Feb 2015.