Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation
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|ClinicalTrials.gov Identifier: NCT03361020|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : January 25, 2019
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.
- 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.
- To identify specific therapeutic factors associated with OSA in adult survivors of HL treated with thoracic radiation.
- To identify biomarkers of OSA in adult survivors of HL treated with thoracic radiation.
- To examine associations between OSA and cardiac morbidity and brain integrity in the adult survivors of HL treated with thoracic radiation.
|Condition or disease|
|Obstructive Sleep Apnea Hodgkin Lymphoma|
Hodgkin lymphoma (HL) survivors being following at St. Jude within the SJLIFE protocol cohort who were treated with TRT will be recruited to complete a comprehensive neurocognitive evaluation, overnight polysomnography evaluation, brain and neck MRI, cervical strength testing, and serum biomarkers related to cardiac disease. As part of their standard SJLIFE evaluation, they will also complete an echocardiogram, pulmonary function tests and questionnaires designed to evaluate broad health, emotional, socioeconomic and environmental factors that impact everyday life.
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.
|Study Type :||Observational|
|Estimated Enrollment :||440 participants|
|Official Title:||Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation|
|Actual Study Start Date :||January 23, 2018|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
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.
- Number of participants with obstructive sleep apnea (OSA) compared between groups [ Time Frame: Once, at enrollment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361020
|Contact: Kevin Krull, PhDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Kevin Krull, PhD 866-278-5833 email@example.com|
|Principal Investigator: Kevin Krull, PhD|
|Principal Investigator: Belinda Mandrell, PhD|
|Principal Investigator:||Kevin Krull, PhD||St. Jude Children's Research Hospital|
|Principal Investigator:||Belinda Mandrell, PhD||St. Jude Children's Research Hospital|