Obstructive Sleep ApneaNCT04003961
Impact of Risk for OSA in Lung Cancer
An observational study of Obstructive Sleep Apnea and Lung Cancer, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: Previous studies have reported that intermittent hypoxia in obstructive sleep apnea (OSA) is associated with tumor progression, metastasis and treatment outcomes. However, studies explaining the relationships between specific types of cancer and OSA are needed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Lung Cancer
- What is being tested?
- STOP- BANG Questionnaire and Epworth sleepiness scale
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 31 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be selected from the palliative care outpatient clinic according to the overmentioned criteria
Who may be able to join
- Patients between 18-75 years of age with the diagnosis of lung cancer (stage 3 and 4 non-small cell lung cancer or limited / extensive small cell lung cancer) and who sign the informed consent to participate in the study
Who cannot join
- Patients older than 75 years old amd younger than 18 years old
- Sedatives / anxiolytic drug users
- Neurological or psychiatric disorders
- Those who have contradictions for standard chemoradiotherapy (ECOG performance status 3-4)
- Stage 1 or stage 2 non-small cell lung cancer patients who may be referred to thoracic surgery
- Patients with brain metastasis
Show all 12Show fewer
- People who have a shift work
- Vena cava superior syndrome
- Alcohol dependence
- Malignant airway stenosis
- Congestive heart failure (EF <50%)
- Patients with chronic renal failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Ankara, 06280
About this study
Official title: The Impact of High Risk for OSA in Prognosis and Treatment Outcomes of Lung Cancer
Background: Previous studies have reported that intermittent hypoxia in obstructive sleep apnea (OSA) is associated with tumor progression, metastasis and treatment outcomes. However, studies explaining the relationships between specific types of cancer and OSA are needed. In this study, it is aimed to show the effect of excessive daytime sleepiness as determined by Epworth sleepiness scale(ESS) and the effect of OSA risk determined by STOP BANG questionnaire on survival and treatment outcomes in lung cancer.
Method: The patients who admit the palliative care outpatient clinic of our hospital with the diagnosis of lung cancer (stage 3 and stage 4 non-small cell lung cancer or limited / extensive stage small cell lung cancer) between July 2019-2020 will be assessed for excessive daytime sleepiness(EDS) and risk of obstructive sleep apnea (OSA) by Epworth sleepiness scale and the STOP-BANG questionnaire. The patients will be grouped according to the risk of OSA and EDS.Total / progression-free survival, treatment outcomes and side effects of the treatment will be evaluated comparatively.
Read the detailed description
The patients who admit the palliative care outpatient clinic of our hospital with the diagnosis of lung cancer (stage 3 and stage 4 non-small cell lung cancer or limited / extensive stage small cell lung cancer) between July 2019-2020 prior to the treatment and the patient who has not yet completed the first-line chemotherapy with a weight loss <10% will be invited to fill the Epworth sleepiness scale and the STOP-BANG questionnaire. Patients' anthropometric measurements (height, weight, BMI, fat-free BMI, neck circumference) will be taken. The treatment outcomes and side-effects in patients with EDS and moderate / high risk for OSA will be compared with patients with low OSA risk. Demographic information (age, gender, smoking history), anthropometric measurements (height, weight, body mass index, fat free body mass index, neck circumference), clinical information (snoring, witnessed apnea, daytime excessive sleep presence of symptoms of symptoms, pulmonary function tests, radiological TNM stages, diagnostic method, diagnosis date, fiberoptic bronchoscopy findings, ECOG performance status, treatment results, treatment-related side effects) laboratory values (complete blood count results albumin, lactate dehydrogenase level) and the results of Epworth sleepiness scale and of STOP-BANG questionnaire will be recorded.
- Conditions
- Obstructive Sleep Apnea, Lung Cancer
- Being tested
- STOP- BANG Questionnaire and Epworth sleepiness scale
- Keywords
- Lung Cancer, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP- BANG Questionnaire and Epworth sleepiness scaleOther
STOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Moderate/high risk for OSA with EDS | All clinical data of the patients who has moderate/high risk for OSA with excessive daytime sleepiness (EDS) will be assessed with statistical methods. Receives: Other: STOP- BANG Questionnaire and Epworth sleepiness scale | |
| Moderate/high risk for OSA without EDS | All clinical data of the patients who has moderate/high risk for OSA without excessive daytime sleepiness(EDS) will be assessed with statistical methods. Receives: Other: STOP- BANG Questionnaire and Epworth sleepiness scale | |
| Low risk for OSA | All clinical data of the patients who has low risk for OSA will be assessed with statistical methods. Receives: Other: STOP- BANG Questionnaire and Epworth sleepiness scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
STOP-BANG questionnaire
OSA - Low Risk : Yes to 0 - 2 questions OSA - Intermediate Risk : Yes to 3 - 4 questions OSA - High Risk : Yes to 5 - 8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference 17 inches / 43cm in male or 16 inches / 41cm in female
Measured: Up to 4 months from the initial diagnosis of lung cancer (the patients who has not initiated or has not finished the first line therapy )
Epworth Sleepiness Scale (ESS)
Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions by which daytime sleepiness in eight different activities is assessed on a 4-point scale (0-3). The ESS score can range from 0 to 24. The higher the ESS score, the higher that person's 'daytime sleepiness'. ESS score ≥ 10 will be used to indicate excessive daytime sleepiness.
Measured: Up to 4 months from the initial diagnosis of lung cancer (the patients who has not initiated or has not finished the first line therapy will be assessed with Epworth Sleepiness Scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sezgi Şahin Duyar, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- Sezgi Şahin Duyar, MD, Study director, Atatürk Chest Diseases and Thoracic Surgery Traininig and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003961
- Sponsor's protocol ID
- 1905
- Status last verified
- Jan 2022
- First submitted
- 21 Jun 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of High Risk for OSA in Prognosis and Treatment Outcomes of Lung Cancer
- ClinicalTrials.gov ID
- NCT04003961
- Acronym / sponsor ID
- 1905
- Conditions
- Obstructive Sleep Apnea, Lung Cancer
- Keywords
- Lung Cancer, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Jul 2019 (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.
Background: Previous studies have reported that intermittent hypoxia in obstructive sleep apnea (OSA) is associated with tumor progression, metastasis and treatment outcomes. However, studies explaining the relationships between specific types of cancer and OSA are needed. In this study, it is aimed to show the effect of excessive daytime sleepiness as determined by Epworth sleepiness scale(ESS) and the effect of OSA risk determined by STOP BANG questionnaire on survival and treatment outcomes in lung cancer.
Method: The patients who admit the palliative care outpatient clinic of our hospital with the diagnosis of lung cancer (stage 3 and stage 4 non-small cell lung cancer or limited / extensive stage small cell lung cancer) between July 2019-2020 will be assessed for excessive daytime sleepiness(EDS) and risk of obstructive sleep apnea (OSA) by Epworth sleepiness scale and the STOP-BANG questionnaire. The patients will be grouped according to the risk of OSA and EDS.Total / progression-free survival, treatment outcomes and side effects of the treatment will be evaluated comparatively.
Detailed description
The patients who admit the palliative care outpatient clinic of our hospital with the diagnosis of lung cancer (stage 3 and stage 4 non-small cell lung cancer or limited / extensive stage small cell lung cancer) between July 2019-2020 prior to the treatment and the patient who has not yet completed the first-line chemotherapy with a weight loss <10% will be invited to fill the Epworth sleepiness scale and the STOP-BANG questionnaire. Patients' anthropometric measurements (height, weight, BMI, fat-free BMI, neck circumference) will be taken. The treatment outcomes and side-effects in patients with EDS and moderate / high risk for OSA will be compared with patients with low OSA risk. Demographic information (age, gender, smoking history), anthropometric measurements (height, weight, body mass index, fat free body mass index, neck circumference), clinical information (snoring, witnessed apnea, daytime excessive sleep presence of symptoms of symptoms, pulmonary function tests, radiological TNM stages, diagnostic method, diagnosis date, fiberoptic bronchoscopy findings, ECOG performance status, treatment results, treatment-related side effects) laboratory values (complete blood count results albumin, lactate dehydrogenase level) and the results of Epworth sleepiness scale and of STOP-BANG questionnaire will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate/high risk for OSA with EDS | – | Other: STOP- BANG Questionnaire and Epworth sleepiness scaleAll clinical data of the patients who has moderate/high risk for OSA with excessive daytime sleepiness (EDS) will be assessed with statistical methods. |
| Moderate/high risk for OSA without EDS | – | Other: STOP- BANG Questionnaire and Epworth sleepiness scaleAll clinical data of the patients who has moderate/high risk for OSA without excessive daytime sleepiness(EDS) will be assessed with statistical methods. |
| Low risk for OSA | – | Other: STOP- BANG Questionnaire and Epworth sleepiness scaleAll clinical data of the patients who has low risk for OSA will be assessed with statistical methods. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be selected from the palliative care outpatient clinic according to the overmentioned criteria
Key inclusion criteria (1 listed)
- Patients between 18-75 years of age with the diagnosis of lung cancer (stage 3 and 4 non-small cell lung cancer or limited / extensive small cell lung cancer) and who sign the informed consent to participate in the study
Key exclusion criteria (12 listed)
- Patients older than 75 years old amd younger than 18 years old
- Sedatives / anxiolytic drug users
- Neurological or psychiatric disorders
- Those who have contradictions for standard chemoradiotherapy (ECOG performance status 3-4)
- Stage 1 or stage 2 non-small cell lung cancer patients who may be referred to thoracic surgery
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 |
|---|---|---|
| STOP- BANG Questionnaire and Epworth sleepiness scaleSTOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes | Other | Low risk for OSA, Moderate/high risk for OSA with EDS, Moderate/high risk for OSA without EDS |
Primary outcome
STOP-BANG questionnaire
Time frame: Up to 4 months from the initial diagnosis of lung cancer (the patients who has not initiated or has not finished the first line therapy )
OSA - Low Risk : Yes to 0 - 2 questions OSA - Intermediate Risk : Yes to 3 - 4 questions OSA - High Risk : Yes to 5 - 8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference 17 inches / 43cm in male or 16 inches / 41cm in female
Epworth Sleepiness Scale (ESS)
Time frame: Up to 4 months from the initial diagnosis of lung cancer (the patients who has not initiated or has not finished the first line therapy will be assessed with Epworth Sleepiness Scale)
Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions by which daytime sleepiness in eight different activities is assessed on a 4-point scale (0-3). The ESS score can range from 0 to 24. The higher the ESS score, the higher that person's 'daytime sleepiness'. ESS score ≥ 10 will be used to indicate excessive daytime sleepiness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Sezgi Şahin Duyar, MD study director
Atatürk Chest Diseases and Thoracic Surgery Traininig and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Lung Cancer, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 4 Jan 2022. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
STOP-BANG questionnaire (time frame: Up to 4 months from the initial diagnosis of lung cancer (the patients who has not initiated or has not finished the first line therapy )). The study lists 2 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 4 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.