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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source |
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Unable to find participants, no enrollment
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Obstructive sleep apnea (OSA) is increasingly recognized in patients with squamous cell carcinoma of the head and neck (SCCHN). The prevalence prior and after cancer therapy is not well understood. OSA is identified as a contributing factor for daytime somnolence and quality of life (QOL), yet treatment of OSA in the SCCHN population has not been studied. The investigators hope to identify the disease course of sleep apnea, risk factors for development, and impact on QOL with treatment of OSA in a population of patients with SCCHN.
The investigators will conduct a prospective cohort study of enrolled patients seen in initial consultation by our H&N cancer surgeons and/or Radiation Oncologists either at AMC or HRH. Data collected from patients in the form of quality of life and sleep questionnaires and home sleep study (Alice Night One System by Phillips Respironics), as well as data from the electronic medical record will be coded into RedCap.
Blood collection for inflammatory biomarkers will occur during routine laboratory workup to avoid unnecessary phlebotomy whenever possible. Blood laboratory specimens of the inflammatory markers will be centrifuged to plasma and stored at -80C in freezers located on the Anschutz campus in Research Complex 2 on the 7th floor. Patients who require tracheostomy will be included in this study but will not have any sleep study time-point as indicated. Patients who are identified to have OSA will undergo counseling and treatment as per standard of care. CPAP compliance data will be collected every three months after initiation of OSA treatment.
Patient details including demographics, treatment information such as surgery, radiation, and chemotherapy, sleep and quality of life questionnaire data, pro-inflammatory cytokines, and sleep study results will collected. The RedCap database will be maintained by the PI, or their delegate of the present study, and all persons utilizing the RedCap database for purposes of entering data will be included on the Delegation of Authority.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research group | Experimental | Sleep apnea testing will be performed with this group, in the form of quality of life and sleep questionnaires, home sleep study results, as well as information collected from their electronic medical record. The investigator will also obtain blood laboratory specimens to measure serum TNF-alpha and IL-6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obstructive sleep apnea testing | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| FOSQ-10 (Functional Outcomes of Sleep Questionnaire) | Measurement of daytime somnolence impact on activities of daily living. Score 0-4 for each item, with a score range of 5-20, higher scores with better outcome | 72 weeks |
| EORTC-HN35 (European Organization for Research and Treatment of Cancer) | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-QLQ-H&N35. Qquality of life assessment in head and neck cancer patients. A raw score is calculated as a mean of the component items, then a linear transformation is performed with score of 0 to 100; the summary score is an average of the raw scores of each group of questions. A higher scores indicate greater impairment. | 72 weeks |
| ESS (Epworth Sleepiness Scale) | A measure of daytime sleepiness. Score 0-4 for each item, score range 0-24, higher scores with worse outcome. | 72 weeks |
| ACE-27 (Adult Comorbidity Evaluation 27) | Comorbidity instrument/severity. Score 0-3 with higher scores with worse outcome. | 72 weeks |
| UW-QOL (University of Washington Quality of Life Questionnaire) | Provides basic quality of life data on the physical, functional, emotional quality of life of the head and neck cancer patient. Score 0-100 with the higher score the better outcome. | 72 weeks |
| Chronic Pain Assessment | Assess chronic pain that changes over time, persistent baseline and breakthrough pain. This isn't scored in the same way, but the severity of pain scale 0-10 and use of medications will be compared. A higher score is worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| 72 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |