Sleep Apnea Hypopnea SyndromeSAILSNCT02687997
Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort
A study testing poligraphy in people with Sleep Apnea Hypopnea Syndrome and COPD, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
Prospective study of sleep disordered breathing in a lung cancer screening cohort. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Hypopnea Syndrome, COPD, Emphysema
- What is being tested?
- poligraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to 31 Jul 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-75.
- > 30 pack years tobacco exposure.
- Enrolled in lung cancer screening program.
Who cannot join
- Inability or unwillingness to undergo a home sleep study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Sleep Apnea in a Lung Cancer Screening Cohort Meeting NLST Criteria
Prospective study of sleep disordered breathing in a lung cancer screening cohort.
Read the detailed description
The proposed study is a prospective single arm study evaluating the prevalence of sleep disordered breathing in a cohort of lung cancer screening patients.
- Conditions
- Sleep Apnea Hypopnea Syndrome, COPD, Emphysema, Lung Cancer
- Being tested
- poligraphy
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Emphysema, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
poligraphyOther
Sleep study
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Experimental | Patients enrolled in lung cancer screening subjected to a sleep study. Receives: Other: poligraphy |
| Contro | No intervention | Patients enrolled in lung cancer screening not included in the diagnostic intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep apnea
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Hypopnea SyndromeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687997
- Sponsor's protocol ID
- InsitutoFJD
- Acronym
- SAILS
- Status last verified
- Sep 2017
- First submitted
- 17 Feb 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sleep Apnea in a Lung Cancer Screening Cohort Meeting NLST Criteria
- ClinicalTrials.gov ID
- NCT02687997
- Acronym / sponsor ID
- SAILS / InsitutoFJD
- Conditions
- Sleep Apnea Hypopnea Syndrome, COPD, Emphysema, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 23 Feb 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.
Prospective study of sleep disordered breathing in a lung cancer screening cohort.
Detailed description
The proposed study is a prospective single arm study evaluating the prevalence of sleep disordered breathing in a cohort of lung cancer screening patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Experimental | Other: poligraphyPatients enrolled in lung cancer screening subjected to a sleep study. |
| Contro | No intervention | –Patients enrolled in lung cancer screening not included in the diagnostic intervention arm |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 55-75.
- > 30 pack years tobacco exposure.
- Enrolled in lung cancer screening program.
Key exclusion criteria (1 listed)
- Inability or unwillingness to undergo a home sleep study.
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 |
|---|---|---|
| poligraphySleep study | Other | Diagnostic |
Primary outcome
Prevalence of sleep apnea
Time frame: 1 year
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 11 Sep 2017.
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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 poligraphy in people with Sleep Apnea Hypopnea Syndrome and COPD, 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 3 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 11 Sep 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 apnea (time frame: 1 year). 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 11 Sep 2017.