Sodium Channel Splicing in Obstructive Sleep Apnea (SOCS-OSA)

NCT02725632 | Completed

• 1 other identifier: 411013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test whether SCN5A mRNA processing is altered in OSA patients, which may contribute to their increased arrhythmic risk, and whether processing of SCN5A mRNA is modulated by CPAP treatment. Specific aims:

1. 1.Compare sodium channel splicing variants in mild, moderate, or severe OSA patients at baseline to at 1 month after CPAP treatment. In addition, the baseline splicing variants of SCN5A in the OSA patients will be compared to an age-matched control group.
2. 2.Hypoxia-associated upstream regulators of SCN5a mRNA splicing, Hypoxia-inducible factor 1-alpha (HIF-1α), RNA Binding Motif Protein 25 (RBM25) and LUC7-Like 3 Pre-MRNA Splicing Factor (LUC7L3), will be examined in OSA patients before and after 1 month of CPAP treatment.

Conditions

Sleep Apnea Syndromes

Keywords

Sodium channel; splicing variant; sleep apnea syndrome

Outcome Measures

Primary Outcomes (1)

• The levels of sodium channel splicing variants that are related to the severity of OSA, change from baseline to one month after CPAP treatment.

  Four weeks

Secondary Outcomes (1)

• The levels of potassium channels that are related to the severity of OSA, change from baseline to one month after CPAP treatment.

  Four weeks

Study Arms (2)

Control

NO INTERVENTION

An age-matched control group will be enrolled and consented. A Data Collection Sheet will be used to document data from the subject's medical records including history, physical exam, active medications, laboratory data, polysomnogram, electrocardiogram, echocardiography and cardiac catheterization. At the time of enrollment, one blood drawn through peripheral venipuncture will be collected. Another blood drawn will be collected after one month. The blood samples will be processed and analyzed to assess for levels of SCN5A mRNA splicing variants.

OSA

ACTIVE COMPARATOR

Newly diagnosed OSA patients will be enrolled and consented. A Data Collection Sheet will be used to document data from the patient's medical records including history, physical exam, active medications, laboratory data, polysomnogram, electrocardiogram, echocardiography and cardiac catheterization. At the time of enrollment, one blood drawn through peripheral venipuncture will be collected. The patients on CPAP treatment will be followed-up for 1 month. Another blood drawn will be collected after one month of CPAP treatment. The blood samples will be processed and analyzed to assess for levels of SCN5A mRNA splicing variants.

Device: CPAP

Interventions

CPAP DEVICE

The patients on CPAP treatment will be followed-up for 1 month.

OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OSA Eligibility Criteria:
• Age greater than 18 years
• Able to provide informed consent
• New diagnosis of OSA by polysomnogram
• Agree with CPAP treatment
• Control Eligibility Criteria:
• Age greater than 18 years
• Without OSA
• Able to provide informed consent

You may not qualify if:

• Not able to give informed consent due to psychological incapacity
• Chronic use of hypnotics for more than 6 weeks
• Current drug or alcohol addiction
• Rhythm other than sinus at enrollment
• Mandatory and biventricular pacing
• History of heart transplant or left ventricular assist device (LVAD)
• Active use of intravenous vasodilators, vasopressors or inotropes
• Hemodialysis or peritoneal dialysis
• Active infection including bacteremia
• Acute coronary syndrome (ACS) within 6 weeks
• Major trauma or surgery within 6 weeks
• Malignant neoplastic disease on active treatment including chemotherapy and radiation therapy, or life expectancy less than 1 year
• Collagen vascular disease on active treatment including steroids and other immunomodulating drugs
• Systemic steroid use within 6 weeks
• Concomitant use of investigational drug within 6 weeks

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Brown University, Lifespan

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

• Hunt SA; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol. 2005 Sep 20;46(6):e1-82. doi: 10.1016/j.jacc.2005.08.022. No abstract available.

  PMID: 16168273 BACKGROUND

• Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.

  PMID: 18086926 BACKGROUND

• Kannel WB, Plehn JF, Cupples LA. Cardiac failure and sudden death in the Framingham Study. Am Heart J. 1988 Apr;115(4):869-75. doi: 10.1016/0002-8703(88)90891-5.

  PMID: 3354416 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Millman, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: April 1, 2016
• Study Start: August 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)