Clinical trial · Interventional
Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to find participants, no enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obstructive Sleep Apnea | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obstructive sleep apnea testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Research group
- description
- 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.
- interventionNames
- Diagnostic Test: Obstructive sleep apnea testing
Primary outcomes (6)
- measure
- FOSQ-10 (Functional Outcomes of Sleep Questionnaire)
- timeFrame
- 72 weeks
- description
- 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
- measure
- EORTC-HN35 (European Organization for Research and Treatment of Cancer)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects between the ages of 21 (inclusive) and 90 (inclusive). Anyone that is over 89 years old will be labeled as 89 in the data analysis. 2. Patients with an established relationship with the adult Otolaryngology and/or Radiation Oncology clinic at AMC or HRH. 3. Patients that present with a new diagnosis of oropharyngeal SCC who undergo radiation treatment, with or without chemotherapy. 4. Patients who may require trachesotomy will be included. 5. Stated willingness to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: 1. Under the age of 21 or over the age of 90. 2. Unwilling to sign the informed consent. 3. Unable or unwilling to participate in sleep studies. 4. Patients who have had a prior diagnosis of SCCa of the head and neck including nasopharynx, oral cavity, oropharynx, larynx and hypopharynx will be excluded. Patients with prior non-cutnaeous non-SCC tumors of the head and neck will also be excluded. Patients with prior skin cancer diagnoses will not be excluded.
References
Publications (0)
Data not yet available