Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation

NCT03361020 | Active Not Recruiting

• 2 other identifiers: APNEAR01CA215405
• Study Type: observational
• Target: 434
• Locations: 1 country
• Sites: 1

Brief Summary

While thoracic radiation therapy (TRT) has been a primary component in successful treatment of Hodgkin lymphoma, exposure to this treatment has been associated with significant cardiovascular, cerebrovascular, and pulmonary morbidity in long-term survivors. Survivors of Hodgkin lymphoma (HL) are also at risk for fatigue and excessive daytime sleepiness. Insufficient sleep is recognized as an important public health concern, and is associated with cardiovascular disease, diabetes, obesity, neurocognitive problems, and reduced quality of life and productivity. Survivors of HL, who are already at risk for cardiac and neurologic morbidity due to their treatment exposures, could face catastrophic cardiovascular and cerebrovascular events with the added risk associated with obstructive sleep apnea (OSA). The investigators propose to examine indices of sleep quality using polysomnography, and associated neurocognitive performance, brain MRI, and structure and strength of neck muscles in 220 long-term adult survivors of Hodgkin lymphoma treated with thoracic radiation. OBJECTIVES:

1. 1.To estimate the prevalence of OSA in adult survivors of HL treated with thoracic radiation, and compare the frequency to community controls matched on age, gender, race and body mass index.
2. 2.To identify specific therapeutic factors associated with OSA in adult survivors of HL treated with thoracic radiation.
3. 3.To identify biomarkers of OSA in adult survivors of HL treated with thoracic radiation.
4. 4.To examine associations between OSA and cardiac morbidity and brain integrity in the adult survivors of HL treated with thoracic radiation.

Conditions

Obstructive Sleep Apnea; Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with obstructive sleep apnea (OSA) compared between groups

  The comparison will be between the Hodgkin lymphoma survivors and race, age, sex, body mass index (BMI) matched control group on frequency of OSA. OSA will be deemed present if either of two conditions is met: (1) polysomnography reveals an apnea hypopnea index (AHI) ≥ 15, or (2) polysomnography reveals an AHI ≥ 5 and the participant presents with clinical symptoms.

  Once, at enrollment

Study Arms (2)

Hodgkin Lymphoma

Participants will be survivors of Hodgkin Lymphoma (HL) who were treated with thoracic radiation during the course of their HL, who meet eligibility criteria, and who consent to this study.

Control Group

The Comparison or control group members will be recruited from healthy parents, sibling, relative or friends who accompany the participant for follow-up at SJCRH and who meet eligibility criteria.

Eligibility Criteria

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

Study Population

Participants will be survivors of Hodgkin Lymphoma (HL) who were treated with thoracic radiation during the course of their HL, who meet eligibility criteria, and who consent to this study. The Comparison or control group members will be recruited from healthy parents, sibling, relative or friends who accompany the participant for follow-up at SJCRH and who meet eligibility criteria.

You may qualify if:

• Current participant in the SJLIFE clinical trial ongoing at St. Jude Children's Research Hospital (SJCRH) and was treated with thoracic radiation for Hodgkin lymphoma
• Currently ≥ 18 years of age
• ≥ 5 years from original diagnosis

You may not qualify if:

• History of cranial or total-body radiation therapy
• History of intrathecal Methotrexate, high-dose Methotrexate, or high-dose Cytarabine.
• History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment
• History of a neurodevelopmental disorder or birth complication associated with neurocognitive impairment
• History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the PIs
• Currently pregnant
• Secondary central nervous system (CNS) neoplasm
• COMPARISON GROUP (CONTROL) ELIGIBILITY CRITERIA
• Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient
• Research participant must be at least 18 years of age at the time of the scheduled evaluation
• History of cranial, total-body or thoracic radiation therapy
• History of intrathecal Methotrexate, high-dose Methotrexate, or high-dose Cytarabine.
• History of head injury or diagnosis of a genetic disorder associated with neurocognitive impairment
• History of a neurodevelopmental disorder or birth complication associated with neurocognitive impairment
• History of congenital heart disease reported in the literature to be associated with neurocognitive status as determined by the PIs

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator
• University of California, San Diego: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hodgkin Disease

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kevin Krull, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

• Belinda Mandrell, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: January 23, 2018
• Primary Completion: July 31, 2023
• Study Completion (Estimated): July 10, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)