CLINICAL TRIAL

Obstructive sleep apnea testing for Head Neoplasms

Recruiting · 18+ · All Sexes · Aurora, CO

This study is evaluating whether obstructive sleep apnea is a risk factor for squamous cell carcinoma of the head and neck.

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About the trial for Head Neoplasms

Eligible Conditions
Obstructive Sleep Apnea (OSA) · Apnea · Sleep Apnea Syndromes · Head and Neck Neoplasms · Squamous Cell Carcinoma of Head and Neck · Sleep Apnea, Obstructive

Treatment Groups

This trial involves 2 different treatments. Obstructive Sleep Apnea Testing is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Obstructive sleep apnea testing
DIAGNOSTICTEST
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who are diagnosed with oropharyngeal SCC and receive radiation therapy have either a good or bad prognosis. show original
Patients who may require a tracheotomy will be included. show original
They are willing to do whatever is asked of them and to be available for the entire study. show original
Subjects aged between 21 and 90 (inclusive), anyone aged 89 or older will be labeled as 89. show original
People who have been going to the adult Otolaryngology and/or Radiation Oncology clinic at AMC or HRH for a while. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 72 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 72 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Obstructive sleep apnea testing will improve 6 primary outcomes in patients with Head Neoplasms. Measurement will happen over the course of 72 weeks.

UW-QOL (University of Washington Quality of Life Questionnaire)
72 WEEKS
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
72 WEEKS
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.
72 WEEKS
EORTC-HN35 (European Organization for Research and Treatment of Cancer)
72 WEEKS
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
FOSQ-10 (Functional Outcomes of Sleep Questionnaire)
72 WEEKS
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
ESS (Epworth Sleepiness Scale)
72 WEEKS
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)
72 WEEKS
Comorbidity instrument/severity. Score 0-3 with higher scores with worse outcome.
72 WEEKS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes head neoplasms?

Most cases were caused by external irradiation and, rarely, by occupational exposure to carcinogenic materials. A plausible biological mechanism is ionizing radiation and external carcinogens that cause genomic damage in neural progenitors.

Anonymous Patient Answer

Does obstructive sleep apnea testing improve quality of life for those with head neoplasms?

Significant gains in QoL are associated with successful performance of ASA testing. The patient with pre-existing medical comorbidities had a significant advantage in QoL outcomes achieved by the intervention of ASA testing.

Anonymous Patient Answer

What are the signs of head neoplasms?

The signs of head neoplasms are headache, nausea and vomiting with loss of appetite as the most commonly reported symptoms. The neurological symptoms are the most frequently reported in children in particular. The signs of intracranial masses are headache, vomiting and neck pain as the most common symptom reported and, in particular, in children below 5 years. Imaging techniques such as CT, MRI of the brain may be helpful in diagnosing certain forms of brain tumours and are especially helpful in diagnosing and classifying central nervous system neoplasms as benign or malignant in the pediatric age group.

Anonymous Patient Answer

What are common treatments for head neoplasms?

The most common treatments include surgical resection, whole brain irradiation, and corticosteroids (in all grades of severity). Stereotactic radiosurgery may also be useful in a few particular cases.

Anonymous Patient Answer

Can head neoplasms be cured?

Treatment options, including surgery and/or radiotherapy, show many positive impacts on the patients quality of life, and can cure around 70% of patients with benign or low malignant brain lesions.

Anonymous Patient Answer

How many people get head neoplasms a year in the United States?

Approximately 1.5 million Americans are diagnosed with a head neoplasm each year. The overall annual prevalence of head and neck cancer is 4.85 per 1000 men and 2.8 per 1000 women in the United States.

Anonymous Patient Answer

What is head neoplasms?

Head neoplasms is the mass that forms in the head due to cells proliferation inside the brain, causing headache. The vast majority of those neoplasms are gliomas. Gliomas contain different kind of cells (astrocytes, oligodendrocytes and neurons) and different types of tumors (well-differentiated or anaplastic gliomas, glioblastoma, multispecific gliomas). Also the tumor form itself (solid, nodular and pseudopapillary shapes) can be seen. In most cases it is treated by surgery and chemotherapy with or without radiation.

Anonymous Patient Answer

Is obstructive sleep apnea testing safe for people?

OSA is extremely common (15% in men and 20% in women) in this population (outpatients at a tertiary care surgical referral center). Our clinical algorithm led to high diagnostic yield of OSA with acceptable rates of PSG-related complications. The most important variables for OSA detection were male gender, low body mass index, and prolonged stay in the ED.

Anonymous Patient Answer

How serious can head neoplasms be?

Head and neck cancer carries a poor prognosis if the tumor invades the bones or the sinuses. When the tumor invades the brain, the prognosis becomes even worse. Tumors located on the cheek, ear, and tongue show longer survival rates when they do not involve these areas. Laryngeal or pharyngeal cancers are in a worse situation as they can extend into the mouth, neck, and pharynx, which will affect the function of these organs. Survival for patients who will have tracheostomy is worse because the cancer may cause obstruction of the airway. The type of surgery used to treat the neoplasm should be chosen so that the most benefit for the patient can be obtained.

Anonymous Patient Answer

What is the average age someone gets head neoplasms?

Head neoplasms are diagnosed at a younger age when compared to other tumors in the body. The average age of a male with a head neoplasm is 40 whereas it is 48 for a female. While there is a positive relationship between the number of CT scans taken and the number of brain tumors to be diagnosed, the age of the first CT scan was not statistically significant. Because these results were obtained while maintaining strict clinical and radiographic guidelines to the study, the reliability of the study may have been compromised.

Anonymous Patient Answer

What is the survival rate for head neoplasms?

The prognosis of head neoplasms depends on the size, type, and stage of cancer as well as the age of the patient. The survival rate decreases when the size of the tumour increases. In the first three years, the survival tends to be good, but in the later years it decreases.

Anonymous Patient Answer

What is obstructive sleep apnea testing?

Patients undergoing OSA testing are often undiagnosed because there is ambiguity in interpreting the results. The OSA test may yield useful information in some patients.

Anonymous Patient Answer
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