Potential Mechanism of Exercise Impairment in OSA

NCT02505594 | Completed

• 1 other identifier: UCSD150468
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a common disorder with major cardiovascular sequelae. A recent study confirmed that OSA is associated with impaired exercise capacity and increasing OSA severity predicts worsening exercise capacity, which is a marker of potential increased cardiovascular risk. However, potential mechanisms of decreased exercise capacity caused by OSA remain unclear. Several pathophysiologic mechanisms of OSA have been proposed and investigators hypothesize that endothelial dysfunction leading to exercise-induced right ventricular dysfunction and associated pulmonary hypertension is the potential mechanism for impaired exercise capacity in OSA.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Vasoreactivity; Endothelial function; Exercise

Outcome Measures

Primary Outcomes (1)

• Endothelial function, as measured by endoPAT, between OSA patients and matched healthy controls

  EndoPAT is a non-invasive measurement of endothelial function, using peripheral arterial tonometry. Exercise tolerance is measured by Cardiopulmonary exercise testing (CPET). Effects of OSA on exercise tolerance and endothelial function will be evaluated.

  Baseline

Secondary Outcomes (14)

• Right ventricular systolic pressure (RVSP) in response to exercise

  Baseline

• Pulmonary systolic pressure (PASP) in response to exercise

  Baseline

• Right ventricular outflow track (RVOT) peak velocity in response to exercise

  Baseline

• Velocity time interval (VTI) in response to exercise

  Baseline

• Pulmonary artery acceleration time in response to exercise

  Baseline

Study Arms (2)

OSA Group

Apnea-hypopnea index (AHI) ≥ 15 events/h

Control Group

Apnea-hypopnea index (AHI) \< 5 events/h

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Investigators will enroll 30 subjects with OSA (OSA group) and 30 subjects without OSA (control group). The detailed inclusion and exclusion criteria for subjects are listed below. Female subjects will be offered a urinary pregnancy test and only those documented to be non-pregnant will be studied.

You may qualify if:

• BMI \< 30
• OSA group: diagnosis of untreated moderate-to-severe OSA (apnea-hypopnea index (AHI) ≥ 15 events/h).
• Control group: no OSA (AHI \< 5 events/h).

You may not qualify if:

• Currently using Continuous Positive Airway Pressure (CPAP) or oral appliance treatment for OSA
• Uncontrolled cardiac co-morbidity, e.g. ischemic heart disease, heart failure, or valvular heart disease that would prevent exercise
• Uncontrolled pulmonary co-morbidity, e.g. asthma or chronic obstructive pulmonary disease (COPD)
• Comorbidities that may severely impair peripheral circulation, e.g. uncontrolled diabetes mellitus, or systemic scleroderma
• Neurological conditions limiting the ability to perform walking or cycling
• Orthopedic condition limiting the ability to perform walking or cycling
• Current smokers, alcohol (\> 3 oz/day) or use of illicit drugs.
• Psychiatric disorder, other than mild and controlled depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
• Pregnancy

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Atul Malhotra, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: January 5, 2018

Record last verified: 2018-01

Locations

US (1)