Obstructive Sleep ApneaOSA-HNNCT04922112
Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado
A study testing Obstructive sleep apnea testing in people with Obstructive Sleep Apnea and Squamous Cell Carcinoma of Head and Neck, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea, Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Obstructive sleep apnea testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients with an established relationship with the adult Otolaryngology and/or Radiation Oncology clinic at AMC or HRH.
- Patients that present with a new diagnosis of oropharyngeal SCC who undergo radiation treatment, with or without chemotherapy.
- Patients who may require trachesotomy will be included.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
Who cannot join
- Under the age of 21 or over the age of 90.
- Unwilling to sign the informed consent.
- Unable or unwilling to participate in sleep studies.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
Read the detailed 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.
- Being tested
- Obstructive sleep apnea testing
- Medical subject headings
- Sleep Apnea, Obstructive, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstructive sleep apnea testingDiagnostic test
- Functional Outcomes of Sleep Questionnaire (FOSQ-10)
- European Organization for Research and Treatment of Cancer Head and Neck Survey (EORTC HN 35)
- Epworth Sleepiness Scale (ESS)
- Adult Comorbidity Evaluation (ACE 27)
- University of Washington Quality of Life Questionnaire (UW-QOL)
- Chronic Pain Assessment Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Obstructive sleep apnea testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 72 weeks
ACE-27 (Adult Comorbidity Evaluation 27)
Comorbidity instrument/severity. Score 0-3 with higher scores with worse outcome.
Measured: 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.
Measured: 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.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start20 Apr 2021
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Why it stopped: Unable to find participants, no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922112
- Sponsor's protocol ID
- 20-1778.cc
- Other IDs
- P30CA046934
- Acronym
- OSA-HN
- Status last verified
- Jul 2023
- First submitted
- 4 Jun 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado
- ClinicalTrials.gov ID
- NCT04922112
- Acronym / sponsor ID
- OSA-HN / 20-1778.cc
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to find participants, no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research group | Experimental | Diagnostic Test: Obstructive sleep apnea testingSleep 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patients with an established relationship with the adult Otolaryngology and/or Radiation Oncology clinic at AMC or HRH.
- Patients that present with a new diagnosis of oropharyngeal SCC who undergo radiation treatment, with or without chemotherapy.
- Patients who may require trachesotomy will be included.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
Key exclusion criteria (4 listed)
- Under the age of 21 or over the age of 90.
- Unwilling to sign the informed consent.
- Unable or unwilling to participate in sleep studies.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstructive sleep apnea testing* Functional Outcomes of Sleep Questionnaire (FOSQ-10) * European Organization for Research and Treatment of Cancer Head and Neck Survey (EORTC HN 35) * Epworth Sleepiness Scale (ESS) * Adult Comorbidity Evaluation (ACE 27) * University of Washington Quality of Life Questionnaire (UW-QOL) * Chronic Pain Assessment Questionnaire | Diagnostic test | Research group |
Primary outcome
FOSQ-10 (Functional Outcomes of Sleep Questionnaire)
Time frame: 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
EORTC-HN35 (European Organization for Research and Treatment of Cancer)
Time frame: 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.
ESS (Epworth Sleepiness Scale)
Time frame: 72 weeks
A measure of daytime sleepiness. Score 0-4 for each item, score range 0-24, higher scores with worse outcome.
ACE-27 (Adult Comorbidity Evaluation 27)
Time frame: 72 weeks
Comorbidity instrument/severity. Score 0-3 with higher scores with worse outcome.
UW-QOL (University of Washington Quality of Life Questionnaire)
Time frame: 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.
Chronic Pain Assessment
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obstructive sleep apnea testing in people with Obstructive Sleep Apnea and Squamous Cell Carcinoma of Head and Neck, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FOSQ-10 (Functional Outcomes of Sleep Questionnaire) (time frame: 72 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.