Extracellular microRNA: Biomarkers of Endothelial Dysfunction in Obese Adolescents & Adults With Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT03546751|
Recruitment Status : Not yet recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Continuous Positive Airway Pressure Other: Diet And Exercise||Not Applicable|
Investigators will randomize 100 OSA patients (age 13-21) to receive either continuous positive airway pressure (CPAP) plus baseline diet/exercise (n=50) or medical management (intensive diet and exercise; n=50). Only children in whom adenotonsillectomy is contraindicated (morbid obesity, history of adenotonsillectomy, lack of adenotonsillar hypertrophy) will be included. Investigators will conduct a randomized prospective comparative effectiveness study to assess the impact of treatment on OSA on endothelial function (peripheral arterial tonometry-EndoPAT). In addition to diagnostic polysomnography and EndoPAT at baseline, EV (extracellular vesicle) and non EV derived miR 92a/miR 210 concentrations, inflammatory cytokines concentrations, and body anthropometry will be measured. Following 3 mos of therapy and after 6mos of therapy, investigators will re-evaluate EndoPAT, EV and non EV derived miR 92a/miR 210 concentrations, inflammatory cytokines, and body anthropometry.
Throughout the study, investigators will maintain weekly telephone contact and monthly face-to-face visits as per standard of care in both groups to ensure ongoing success. In the medical management group (intensive diet and exercise), diet and exercise will be tracked by maintaining weekly telephone contact and monthly face-to-face visits with a registered dietician. For the CPAP group, investigators will also maintain weekly telephone contact and monthly face-to-face visits with a sleep technician to review mask fitting, and adherence reports, to optimize adherence to CPAP therapy.
Following completion at six months, polysomnography will be repeated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Comparative Effectiveness Trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Investigators will randomize two groups of patients with OSA to receive either CPAP or intensive exercise. The study biostatistician will ensure that matching results in equal distributions of patients based on sex, age, race, severity of OSA, and obesity status.|
|Official Title:||Extracellular Micro RNA (miR) (Extracellular Vesicle (EV)-Associated & Non-EV-associated miRs) Identify and Mediate Endothelial Dysfunction in Obesity and Obstructive Sleep Apnea in Adolescents & Young Adults|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||July 30, 2024|
|Estimated Study Completion Date :||December 31, 2024|
This arm will consist of patients with obstructive sleep apnea who will be asked to use CPAP nightly to treat their OSA for six months
Device: Continuous Positive Airway Pressure
This device delivers air pressure non invasively through a mask to stent open the upper airway to prevent obstruction during sleep. This is an FDA approved device that has been used for several decades to treat OSA.
Other Name: CPAP
Active Comparator: Diet and Exercise
This arm will consist of patients with obstructive sleep apnea who will be asked to engage in dietary management and regular exercise for six months.
Other: Diet And Exercise
This will consist of weekly telephone and monthly face to face visits to monitor and suggest measures to improve diet and regular exercise as conducted by a registered dietician.
- Peripheral Arterial Tonometry - Reactive Hyperemic Index [ Time Frame: At baseline. ]EndoPAT
- Peripheral Arterial Tonometry - Reactive Hyperemic Index [ Time Frame: At three months. ]EndoPAT
- Peripheral Arterial Tonometry - Reactive Hyperemic Index [ Time Frame: At six months. ]EndoPAT
- miRNA 92a and miRNA 210 levels [ Time Frame: At baseline. ]Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
- miR 92a and miR 210 levels [ Time Frame: At three months. ]Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
- miR 92a and miR 210 levels [ Time Frame: At six months. ]Serum and Extracellular Vesicle derived miR 92a and miR 210 levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546751
|Contact: Rakesh Bhattacharjee, MDemail@example.com|