Extracellular microRNA: Biomarkers of Endothelial Dysfunction in Obese Adolescents & Adults With Obstructive Sleep Apnea

NCT03546751 | Unknown DMC

• 1 other identifier: 170408
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Keywords

Endothelial Dysfunction; Micro RNA

Outcome Measures

Primary Outcomes (3)

• Peripheral Arterial Tonometry - Reactive Hyperemic Index

  EndoPAT

  At baseline.

• Peripheral Arterial Tonometry - Reactive Hyperemic Index

  EndoPAT

  At three months.

• Peripheral Arterial Tonometry - Reactive Hyperemic Index

  EndoPAT

  At six months.

Secondary Outcomes (3)

• miRNA 92a and miRNA 210 levels

  At baseline.

• miR 92a and miR 210 levels

  At three months.

• miR 92a and miR 210 levels

  At six months.

Study Arms (2)

CPAP

EXPERIMENTAL

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

Diet and Exercise

ACTIVE COMPARATOR

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

Interventions

Continuous Positive Airway Pressure DEVICE

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.

Also known as: CPAP

CPAP

Diet And Exercise OTHER

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.

Diet and Exercise

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Related Publications (1)

• Bhattacharjee R, Khalyfa A, Khalyfa AA, Mokhlesi B, Kheirandish-Gozal L, Almendros I, Peris E, Malhotra A, Gozal D. Exosomal Cargo Properties, Endothelial Function and Treatment of Obesity Hypoventilation Syndrome: A Proof of Concept Study. J Clin Sleep Med. 2018 May 15;14(5):797-807. doi: 10.5664/jcsm.7110.

  PMID: 29734990 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure; Diet; Exercise

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Rakesh Bhattacharjee, MD

CONTACT

858-966-5846; rakesh@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics

Model Details: Comparative Effectiveness Trial

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 6, 2018
• Study Start: April 1, 2019
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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