Sleep Apnea in Head & Neck Cancer Patients at the University of Colorado

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Apnea
Head and Neck Neoplasms
Obstructive Sleep Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Squamous Cell Carcinoma of Head and Neck

Clinical Trial Details

NCT number	NCT04922112
Study type	Interventional
Source	University of Colorado, Denver
Contact
Status	Withdrawn
Phase	N/A
Start date	April 20, 2021
Completion date	September 28, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado — OSA-HN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms