Lung CancerSAILNCT02764866
Sleep Apnea in Lung Cancer: A Prospective Study
A study testing Sleep testing in people with Lung Cancer and Sleep-Disordered Breathing, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer, Sleep-Disordered Breathing
- What is being tested?
- Sleep testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Nov 2017
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with recently diagnosed lung cancer, inlcuding all stages of disease.
Who cannot join
- Patients unable to comply with home sleep testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Sleep Apnea in Lung Cancer
The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer.
Read the detailed description
Obstructive sleep apnea hypopnea syndrome (OSAHS) is an important medical condition which causes significant morbidity and mortality. The prevalence of OSAHS in Spain is 4-6% in men and 2-4% in women and rises steadily with age. Snoring and smoking have been independently linked, and smoking may be a risk factor for developing OSAHS. This is particularly true of heavy smokers (> 2 packs/day), those at greatest risk for LC. Associations between OSAHS and some forms of cancer have been described in humans, especially in those experiencing nocturnal hypoxemia, and intermittent hypoxia has been linked to the progression of cancer in animal models. LC is currently the leading cause of cancer deaths in developped nations. A link between OSAHS and LC, therefore, is plausible.
Sleep disordered breathing may be common among patients recently diagnosed of lung cancer and may contribute to tumor progression.
Objectives: a) To perform home sleep testing in patients recently diagnosed with lung cancer in order to determine the prevalence of sleep disordered breathing in this patient population. b) To include biological samples obtained from all participants, including surgically treated patients with stage I / IIp LC through the program in the CIBERES Pulmonary Biobank Platform. Biological samples will be preserved under different storage conditions for subsequent determination of molecular biomarkers. c) To follow-up lung cancer patients with and without sleep disordered breathing in order to determine the potential influence OSAHS might have on their prognosis.
Prospective screening for sleep disordered breathing will be performed by home sleep testing in 100 subjects diagnosed with lung cancer, irrespective of stage at diagnosis, who give their consent. A modified epidemiologic questionnaire for sleep disordered breathing will also be administered. Patients identified as suffering from OSAHS will be referred to sleep clinic. Biologic samples and lung function studies will be obtained in all participating patients.
All patients with lung cancer will undergo follow-up for at least three years or until their demise, and those identified with OSAHS will also be followed in sleep clinic. The prevalence of OSAHS in this patient population will be determined. A link between OSAHS, and especially intermittent nocturnal hypoxemia, and tumor progression will be sought.
- Conditions
- Lung Cancer, Sleep-Disordered Breathing
- Being tested
- Sleep testing
- Keywords
- Lung cancer, Sleep apnea, Sleep disordered breathing
- Medical subject headings
- Lung Neoplasms, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep testingOther
Home sleep testing
| Study group | Role | What they receive |
|---|---|---|
| Sleep testing | Experimental | Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment. Receives: Other: Sleep testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep disordered breathing in lung cancer
Measured: 12 months
Secondary outcomes (3)
Survival of lung cancer in patients with sleep disordered breathing
Measured: 36 months
Lung cancer stage in patients with sleep disordered breathing
Measured: 12 months
Lung cancer progression free survival in patients with sleep disordered breathing
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUIS SEIJO MACEIRAS, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- Luis M Seijo, MD, PhD, Principal investigator, Instituto de Investigacion Fundacion Jimenez Diaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764866
- Sponsor's protocol ID
- InstitutoFJD
- Acronym
- SAIL
- Status last verified
- Nov 2017
- First submitted
- 4 May 2016
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Seijo LM, Perez-Warnisher MT, Giraldo-Cadavid LF, Oliveros H, Cabezas E, Troncoso MF, Gomez T, Melchor R, Pinillos EJ, El Hachem A, Gotera C, Rodriguez P, Gonzalez-Mangado N, Peces-Barba G. Obstructive sleep apnea and nocturnal hypoxemia are associated with an increased risk of lung cancer. Sleep Med. 2019 Nov;63:41-45. doi: 10.1016/j.sleep.2019.05.011. Epub 2019 Jun 6.
PubMed 31605903
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sleep Apnea in Lung Cancer
- ClinicalTrials.gov ID
- NCT02764866
- Acronym / sponsor ID
- SAIL / InstitutoFJD
- Conditions
- Lung Cancer, Sleep-Disordered Breathing
- Keywords
- Lung cancer, Sleep apnea, Sleep disordered breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer.
Detailed description
Obstructive sleep apnea hypopnea syndrome (OSAHS) is an important medical condition which causes significant morbidity and mortality. The prevalence of OSAHS in Spain is 4-6% in men and 2-4% in women and rises steadily with age. Snoring and smoking have been independently linked, and smoking may be a risk factor for developing OSAHS. This is particularly true of heavy smokers (> 2 packs/day), those at greatest risk for LC. Associations between OSAHS and some forms of cancer have been described in humans, especially in those experiencing nocturnal hypoxemia, and intermittent hypoxia has been linked to the progression of cancer in animal models. LC is currently the leading cause of cancer deaths in developped nations. A link between OSAHS and LC, therefore, is plausible.
Sleep disordered breathing may be common among patients recently diagnosed of lung cancer and may contribute to tumor progression.
Objectives: a) To perform home sleep testing in patients recently diagnosed with lung cancer in order to determine the prevalence of sleep disordered breathing in this patient population. b) To include biological samples obtained from all participants, including surgically treated patients with stage I / IIp LC through the program in the CIBERES Pulmonary Biobank Platform. Biological samples will be preserved under different storage conditions for subsequent determination of molecular biomarkers. c) To follow-up lung cancer patients with and without sleep disordered breathing in order to determine the potential influence OSAHS might have on their prognosis.
Prospective screening for sleep disordered breathing will be performed by home sleep testing in 100 subjects diagnosed with lung cancer, irrespective of stage at diagnosis, who give their consent. A modified epidemiologic questionnaire for sleep disordered breathing will also be administered. Patients identified as suffering from OSAHS will be referred to sleep clinic. Biologic samples and lung function studies will be obtained in all participating patients.
All patients with lung cancer will undergo follow-up for at least three years or until their demise, and those identified with OSAHS will also be followed in sleep clinic. The prevalence of OSAHS in this patient population will be determined. A link between OSAHS, and especially intermittent nocturnal hypoxemia, and tumor progression will be sought.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep testing | Experimental | Other: Sleep testingEnrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with recently diagnosed lung cancer, inlcuding all stages of disease.
Key exclusion criteria (1 listed)
- Patients unable to comply with home sleep testing.
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 |
|---|---|---|
| Sleep testingHome sleep testing | Other | Sleep testing |
Primary outcome
Prevalence of sleep disordered breathing in lung cancer
Time frame: 12 months
3 secondary outcomes
Survival of lung cancer in patients with sleep disordered breathing
Time frame: 36 months
Lung cancer stage in patients with sleep disordered breathing
Time frame: 12 months
Lung cancer progression free survival in patients with sleep disordered breathing
Time frame: 36 months
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 9 Nov 2017.
- Derived from this study: PubMed 31605903Seijo LM, Perez-Warnisher MT, Giraldo-Cadavid LF, Oliveros H, Cabezas E, Troncoso MF, Gomez T, Melchor R, Pinillos EJ, El Hachem A, Gotera C, Rodriguez P, Gonzalez-Mangado N, Peces-Barba G. Obstructive sleep apnea and nocturnal hypoxemia are associated with an increased risk of lung cancer. Sleep Med. 2019 Nov;63:41-45. doi: 10.1016/j.sleep.2019.05.011. Epub 2019 Jun 6.
- Lung cancer screening home web pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Luis M Seijo, MD, PhD principal investigator
Instituto de Investigacion Fundacion Jimenez Diaz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep testing in people with Lung Cancer and Sleep-Disordered Breathing, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 1 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 9 Nov 2017. 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 Spain. 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?
Prevalence of sleep disordered breathing in lung cancer (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764866, which also lists 1 linked publication.
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 9 Nov 2017.