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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 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Rakesh Bhattacharjee, University of California, San Diego

Brief Summary:
Using a prospective observational approach and a clinical trial design comparing the effectiveness of continuous positive airway pressure to diet and exercise, investigators plan to evaluate how obstructive sleep apnea (OSA) leads to endothelial dysfunction in adolescents and young adults and whether treatment of OSA can improve endothelial dysfunction. Concurrently, investigators will measure miR 92a/miR 210 levels in all subjects at baseline and following therapy to determine whether miR 92a/miR 210 levels reliably predict endothelial dysfunction in patients and responses to therapy.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Continuous Positive Airway Pressure Other: Diet And Exercise Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPAP
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.




Primary Outcome Measures :
  1. Peripheral Arterial Tonometry - Reactive Hyperemic Index [ Time Frame: At baseline. ]
    EndoPAT

  2. Peripheral Arterial Tonometry - Reactive Hyperemic Index [ Time Frame: At three months. ]
    EndoPAT

  3. Peripheral Arterial Tonometry - Reactive Hyperemic Index [ Time Frame: At six months. ]
    EndoPAT


Secondary Outcome Measures :
  1. miRNA 92a and miRNA 210 levels [ Time Frame: At baseline. ]
    Serum and Extracellular Vesicle derived miR 92a and miR 210 levels

  2. miR 92a and miR 210 levels [ Time Frame: At three months. ]
    Serum and Extracellular Vesicle derived miR 92a and miR 210 levels

  3. miR 92a and miR 210 levels [ Time Frame: At six months. ]
    Serum and Extracellular Vesicle derived miR 92a and miR 210 levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy children and young adults with a diagnosis of obstructive sleep apnea based on polysomnography criteria of an obstructive apnea hypopnea index > 10 events/hr.
  • For children a BMI range up to 99.7% and for adults BMI up to 32 kg/m2 is used.

Exclusion Criteria:

  • The presence of elevated blood pressure
  • The presence of diabetes or pre-diabetes
  • The presence of craniofacial anomalies
  • The presence of neuromuscular disorders
  • The presence of syndromic or defined genetic abnormalities
  • Pregnancy
  • History of smoking (any smoking within the prior 6 mos or >5 pack years total)
  • The presence of infectious disease (e.g. including hepatitis B, C, HIV etc.)
  • The presence of collagen vascular disease (e.g. lupus, arthritis, scleroderma, polymyositis, mixed-connective tissue disease, vasculitis etc)
  • The presence of hepatic disease (including hepatitis fatty liver or cirrhosis)
  • The presence of renal disease (including azotemia or clinical proteinuria)
  • The presence of cardiopulmonary disease (e.g. known asthma, cystic fibrosis, congenital heart disease)
  • Individuals using medications which could affect sleep or breathing (including hypnotics)
  • Individuals using chronic anti-inflammatory therapy
  • Individuals with any subjects with acute or chronic illness.
  • Individuals using anti-hypertensive therapies
  • Children with a a BMI > 99.7%
  • Adults with a BMI > 32 kg/m2

Information from the National Library of Medicine

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


Contacts
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Contact: Rakesh Bhattacharjee, MD 858-966-5846 rakesh@ucsd.edu

Sponsors and Collaborators
University of California, San Diego

Publications:
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Responsible Party: Rakesh Bhattacharjee, Associate Professor of Clinical Pediatrics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03546751     History of Changes
Other Study ID Numbers: 170408
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Intellectual property and data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.

As a part of this application will involve human subjects, investigators believe that the rights and privacy of people who will participate in the research project must be protected at all times. In case other investigators express interest in working with the data, every effort will be made to provide the data to them free of identifiers. However, such endeavors will have to be individually considered and also approved by the University of California (UC) San Diego Human Research Protection Program before any commitments can be made.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 5 years (during the study period)
Access Criteria: Only investigators that are listed as co-investigators with the UC San Diego Human Research Protection Program

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rakesh Bhattacharjee, University of California, San Diego:
Endothelial Dysfunction
Micro RNA
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases