Football Players Health Study In Person Assessments Study

NCT03866564 | Completed FDA Drug

• 1 other identifier: 2018P001929
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the Football Players Health Study (FPHS) is to advance the understanding of the complex and inter-related pathways that can develop into player related illness and disability. Former National Football League players will be given the opportunity to undergo 2\&1/2 days of rigorous assessment in the areas of Cardiac Dysfunction, Neurocognitive Disease, Chronic Pain, and Sleep Apnea to attempt to define the pathology among former professional athletes.

Conditions

Cardiac Dysfunction; Neurocognitive Disease; Chronic Pain; Sleep Apnea

Outcome Measures

Primary Outcomes (4)

• Cardiac Dysfunction

  Measurement of Left Ventricular Systolic Function (Ejection Fraction) by Transthoracic Echocardiography

  Study visit day 3

• Neurocognitive Disease

  Performance on Standard Clinical Neuropsychological Testing to Establish or Exclude Cognitive Impairment.

  Study visit day 2

• Chronic Pain: Pain Catastrophizing Scale

  Performance on Pain Catastrophizing Scale to Quantify the Magnitude of Chronic Pain. The range of this scale is from 0 to 52. The higher the score, the higher the presence of catastrophizing thoughts. A score of 30 or greater will be used to determine magnitude of pain that is clinically relevant

  Study visit day 2

• Sleep Apnea

  Measurement of the Apnea-Hypopnea Index via Conventional Nocturnal Polysomnography. The Apnea-Hypopnea Index (AHI) is the measure of the number of apnea or hypopnea events measured in a one hour period. 0-5 events are normal, 6-15 events indicate mild sleep apnea, 16-30 events indicate moderate sleep apnea, over 30 events indicate sever sleep apnea. Scores of \>15 will be considered positive for sleep apnea

  study visit day 2

Study Arms (3)

Multi-Afflicted

Participants with multiple self reported afflictions will undergo comprehensive research health screenings including Echocardiography (to define cardiac dysfunction), Neuropsychological Testing (to define neurocognitive disease), Pain Catastrophizing Scale (to define chronic pain), and Nocturnal Polysomnography (to define sleep apnea).

Diagnostic Test: Echocardiography; Diagnostic Test: Neuropsychological Testing; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Nocturnal Polysomnography

Un-Afflicted

Participants who report no afflictions will undergo comprehensive research health screenings including Echocardiography (to define cardiac dysfunction), Neuropsychological Testing (to define neurocognitive disease), Pain Catastrophizing Scale (to define chronic pain), and Nocturnal Polysomnography (to define sleep apnea).

Diagnostic Test: Echocardiography; Diagnostic Test: Neuropsychological Testing; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Nocturnal Polysomnography

Single Afflicted

Participants with one self reported afflictions will undergo comprehensive research health screenings including Echocardiography (to define cardiac dysfunction), Neuropsychological Testing (to define neurocognitive disease), Pain Catastrophizing Scale (to define chronic pain), and Nocturnal Polysomnography (to define sleep apnea).

Diagnostic Test: Echocardiography; Diagnostic Test: Neuropsychological Testing; Diagnostic Test: Quantitative Sensory Testing; Diagnostic Test: Nocturnal Polysomnography

Interventions

Echocardiography DIAGNOSTIC_TEST

Cardiac ultrasound to measure left ventricular systolic function.

Multi-Afflicted; Single Afflicted; Un-Afflicted

Neuropsychological Testing DIAGNOSTIC_TEST

Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.

Multi-Afflicted; Single Afflicted; Un-Afflicted

Quantitative Sensory Testing DIAGNOSTIC_TEST

Clinically accepted quantitative assessment of chronic pain burden.

Multi-Afflicted; Single Afflicted; Un-Afflicted

Nocturnal Polysomnography DIAGNOSTIC_TEST

Routine overnight sleep study to measure apnea-hypopnea index.

Multi-Afflicted; Single Afflicted; Un-Afflicted

Eligibility Criteria

• Age: 24 Years - 55 Years
• Gender Eligibility Details: Women are not included in this study, as the National Football League is historically and currently a male-only entity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Former Professional American-Style Football Players

You may qualify if:

• Age 24-55 at the time of first Health and Wellness Questionnaire (Q1) completion.
• Former professional football player who played between 1960 to present.
• Prior completed the first Health and Wellness Questionnaire (Q1)
• "Healthy" subjects: ability to give informed consent and comply with study procedures.
• "Afflicted" participants: must meet criteria for at least one of the following subjective afflictions based on Q1 responses: 1) Cardiovascular Dysfunction, 2) Neurocognitive Disease, 3) Chronic Pain, and/or 4) Sleep Apnea

You may not qualify if:

• Prior metallic device implants such as cardiac pacemakers/defibrillators or perfusion pumps that cannot be removed.
• Ferromagnetic implants or objects that cannot be removed such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants or jewelry
• Body weight \>390 lbs at screening
• Inability to complete the telephone screener
• Low T-MoCA score (\<17) and absence of an available study partner if required following MD review.
• Significant behavioral or functional disability due to cognitive impairment

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Martinos Center for Biomedical Imaging: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma \& Serum

MeSH Terms

Conditions

Chronic Pain; Sleep Apnea Syndromes

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Meagan M Wasfy, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: March 7, 2019
• Study Start: April 22, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: May 8, 2024

Record last verified: 2024-03

Locations

US (1)