Obstructive Sleep ApneaEPIMOOSANCT03995836
Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients: The EPIMOOSA Study
An observational study of Obstructive Sleep Apnea and Morbid Obesity, run by Aragon Institute of Health Sciences.
Trial summary
This study evaluates epigenetics in morbid obese patients who are waiting for bariatric surgery. A home cardiopulmonary polygraphy is performed to evaluate for the presence of sleep-disordered breathing. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea, Morbid Obesity, Epigenetic Disorder
- What is being tested?
- CPAP and Bariatric Surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 1 Jul 2018
- 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 18 to 60 years
- All sexes
- Adult
Study population: Bariatric surgery waiting list in Royo Villanova Hospital
Who may be able to join
- BMI consistently > 40 kg/m2 for 3-5 years, following more than 1 year of unsuccessful controlled medical treatment
- BMI 35-40 kg/m2 with comorbidities associated with morbid obesity (MO) susceptible to improvement with weight loss (high BP, Diabetes, dyslipidemia, OSA, etc.), following more than 1 year of unsuccessful controlled medical treatment.
- A signed informed consent form
Who cannot join
- Obesity hypoventilation syndrome or treatment with positive pressure devices.
- Diagnosis of systemic inflammatory disease.
- Neoplastic diseases in the last 5 years.
- A cardiovascular event in the last 6 months.
- Pregnancy
About this study
Official title: Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients (EPIMOOSA): Continous Positive Airway Pressure (CPAP) and Bariatric Surgery Impact. EPIMOOSA Study
This study evaluates epigenetics in morbid obese patients who are waiting for bariatric surgery. A home cardiopulmonary polygraphy is performed to evaluate for the presence of sleep-disordered breathing. The principal investigator make the decision of starting CPAP among patients with obstructive sleep apnea according to current clinical guidelines. One year follow up after bariatric surgery will be performed. A total of 5 visits will be scheduled: two of them before bariatric surgery and 3 after (3, 6 and 12 months).
At every visit, all patients had: sleep questionaries, blood samples, EKG-Holter and spirometry are collected.
- Conditions
- Obstructive Sleep Apnea, Morbid Obesity, Epigenetic Disorder
- Being tested
- CPAP, Bariatric Surgery
- Keywords
- Obstructive Sleep Apnea, Morbid Obesity, Epigenetics, Bariatric Surgery
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Decision of CPAP treatment is according to clinical guidelines
Bariatric SurgeryProcedure or surgery
All patients.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | Not described Receives: Device: CPAP; Procedure: Bariatric Surgery | |
| Non Obstructive Sleep Apnea | Not described Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA)
To evaluate differences in miRNA profile among patients with morbid obesity with or without OSA Differences between exosome miRNA of MO+OSA and MO-OSA will be calculated. The results will be expressed following the method 2(delta-delta C(T)) miRNA will be analyzed: miRNA 16, 21, 34, 126, 133, 145, 146, 155, 223, 320.
Measured: 2 years
Secondary outcomes (2)
Impact of CPAP treatment in epigenetics changes.
miRNA profile will be assessed In patient with morbid obesity and coexistent OSA, at baseline and after 6 months of treatment with CPAP according with current guidelines.
Measured: 6 months
Impact of weight loss due to bariatric surgery in epigenetics changes.
All participants included will go to bariatric surgery and 3, 6 and 12 month blood samples will be obtained.
miRNA will be analyzed in the last 2 visits and compared with previous.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Jul 2014
- Primary completion1 Jul 2016
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aragon Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JAVIER LAZARO SIERRA, MD, Principal investigator, Hospital Universitario Royo Villanova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995836
- Sponsor's protocol ID
- 23/2014
- Acronym
- EPIMOOSA
- Status last verified
- Jun 2019
- First submitted
- 13 May 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lazaro J, Sanz-Rubio D, Claveria P, Cabrejas C, Fernando J, Castanera A, Marin JM. Effect of positive pressure ventilation and bariatric surgery on extracellular vesicle microRNAs in patients with severe obesity and obstructive sleep apnea. Int J Obes (Lond). 2023 Jan;47(1):24-32. doi: 10.1038/s41366-022-01230-z. Epub 2022 Oct 25.
PubMed 36284205Lazaro J, Claveria P, Cabrejas C, Fernando J, Daga B, Ordonez B, Segura S, Sanz-Rubio D, Marin JM. Epigenetics dysfunction in morbid obesity with or without obstructive sleep apnoea: the EPIMOOSA study. Respir Res. 2020 Feb 4;21(1):42. doi: 10.1186/s12931-020-1302-9.
PubMed 32019550
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients (EPIMOOSA): Continous Positive Airway Pressure (CPAP) and Bariatric Surgery Impact. EPIMOOSA Study
- ClinicalTrials.gov ID
- NCT03995836
- Acronym / sponsor ID
- EPIMOOSA / 23/2014
- Conditions
- Obstructive Sleep Apnea, Morbid Obesity, Epigenetic Disorder
- Keywords
- Obstructive Sleep Apnea, Morbid Obesity, Epigenetics, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aragon Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 24 Jun 2019 (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.
This study evaluates epigenetics in morbid obese patients who are waiting for bariatric surgery. A home cardiopulmonary polygraphy is performed to evaluate for the presence of sleep-disordered breathing. The principal investigator make the decision of starting CPAP among patients with obstructive sleep apnea according to current clinical guidelines. One year follow up after bariatric surgery will be performed. A total of 5 visits will be scheduled: two of them before bariatric surgery and 3 after (3, 6 and 12 months).
At every visit, all patients had: sleep questionaries, blood samples, EKG-Holter and spirometry are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | – | Device: CPAP, Procedure: Bariatric Surgery |
| Non Obstructive Sleep Apnea | – | Procedure: Bariatric Surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Bariatric surgery waiting list in Royo Villanova Hospital
Key inclusion criteria (3 listed)
- BMI consistently > 40 kg/m2 for 3-5 years, following more than 1 year of unsuccessful controlled medical treatment
- BMI 35-40 kg/m2 with comorbidities associated with morbid obesity (MO) susceptible to improvement with weight loss (high BP, Diabetes, dyslipidemia, OSA, etc.), following more than 1 year of unsuccessful controlled medical treatment.
- A signed informed consent form
Key exclusion criteria (5 listed)
- Obesity hypoventilation syndrome or treatment with positive pressure devices.
- Diagnosis of systemic inflammatory disease.
- Neoplastic diseases in the last 5 years.
- A cardiovascular event in the last 6 months.
- Pregnancy
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 |
|---|---|---|
| CPAPDecision of CPAP treatment is according to clinical guidelines | Device | Obstructive Sleep Apnea |
| Bariatric SurgeryAll patients. | Procedure or surgery | Non Obstructive Sleep Apnea, Obstructive Sleep Apnea |
Primary outcome
Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA)
Time frame: 2 years
To evaluate differences in miRNA profile among patients with morbid obesity with or without OSA Differences between exosome miRNA of MO+OSA and MO-OSA will be calculated. The results will be expressed following the method 2(delta-delta C(T)) miRNA will be analyzed: miRNA 16, 21, 34, 126, 133, 145, 146, 155, 223, 320.
2 secondary outcomes
Impact of CPAP treatment in epigenetics changes.
Time frame: 6 months
Impact of weight loss due to bariatric surgery in epigenetics changes.
Time frame: 12 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 24 Jun 2019.
- Derived from this study: PubMed 36284205Lazaro J, Sanz-Rubio D, Claveria P, Cabrejas C, Fernando J, Castanera A, Marin JM. Effect of positive pressure ventilation and bariatric surgery on extracellular vesicle microRNAs in patients with severe obesity and obstructive sleep apnea. Int J Obes (Lond). 2023 Jan;47(1):24-32. doi: 10.1038/s41366-022-01230-z. Epub 2022 Oct 25.
- Derived from this study: PubMed 32019550Lazaro J, Claveria P, Cabrejas C, Fernando J, Daga B, Ordonez B, Segura S, Sanz-Rubio D, Marin JM. Epigenetics dysfunction in morbid obesity with or without obstructive sleep apnoea: the EPIMOOSA study. Respir Res. 2020 Feb 4;21(1):42. doi: 10.1186/s12931-020-1302-9.
- Individual participant dataSharing planned: Undecided
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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.
JAVIER LAZARO SIERRA, MD principal investigator
Hospital Universitario Royo Villanova
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Morbid Obesity, run by Aragon Institute of Health Sciences.
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 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: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995836, which also lists 2 linked publications.
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 24 Jun 2019.