Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation
NCT ID: NCT03361020
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
434 participants
OBSERVATIONAL
2018-01-23
2028-07-10
Brief Summary
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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. 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. To identify specific therapeutic factors associated with OSA in adult survivors of HL treated with thoracic radiation.
3. To identify biomarkers of OSA in adult survivors of HL treated with thoracic radiation.
4. To examine associations between OSA and cardiac morbidity and brain integrity in the adult survivors of HL treated with thoracic radiation.
Detailed Description
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The investigators will also recruit a comparison sample of healthy individuals matching on age, sex, race and body mass index. The comparison group will complete the comprehensive neurocognitive evaluation, overnight polysomnography, neck MRI, and cervical strength testing.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Currently ≥ 18 years of age
* ≥ 5 years from original diagnosis
* 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
Exclusion Criteria
* 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
* 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
* Currently pregnant
* History of cancer
* 1st degree relative of a survivor included in the current study.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Diego
OTHER
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Kevin Krull, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Belinda Mandrell, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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APNEA
Identifier Type: -
Identifier Source: org_study_id