Cell Lung CancerSomOncoPNCT06495346
Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer
An observational study of Cell Lung Cancer and Sleep Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. This will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cell Lung Cancer, Sleep Disorders
- What is being tested?
- self-questionnaires exploring
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2023to 25 Mar 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a diagnosis of non-small cell lung cancer followed and treated by the Oncopneumology Department of the Nouvel Hôpital Civil in Strasbourg
Who may be able to join
- Patient aged 18 and over.
- Being monitored and treated for non-small cell lung cancer.
- With or without ongoing cancer-specific treatment. With no neurocognitive impairment (MoCA test score ≥26/30).
- With a clinically assessed life expectancy of more than 3 months (Royal Marsden Hospital 0-1) and general health (ECOG <2).
- Able to understand the study documents written in French
- Able to complete the study questionnaires written in French.
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- Contactable by telephone throughout the study
- Affiliated to a social security scheme or entitled beneficiary
- Not opposed to taking part in the study
Who cannot join
- Patient refusing to take part in the study
- With a mental illness of the psychosis type monitored and treated prior to the study
- Patient under guardianship or curatorship
- Patient under court protection
Trial locations and contacts
1 site in 1 country.
About this study
This exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. This will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population.
This decision tree should help to improve the management of patients with a cancer diagnosis presenting with sleep disorders.
- Conditions
- Cell Lung Cancer, Sleep Disorders
- Being tested
- self-questionnaires exploring
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnaires exploringOther
At each stage, subjects are asked to fill in self-questionnaires exploring the quality of their sleep, their potential distressing symptoms, their psychological state and the quality of their life at that moment. They complete the self-questionnaires at t
What is being measured
The primary outcome is the main question the study is designed to answer.
Score sleep quality criteria (Pittsburgh Sleep Quality Index)
The overall score ranging from 0 to 21 points. A score of 0 means that there is no difficulty sleeping, and 21 indicates, on the contrary, major difficulties.
Measured: Every 14 days for 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start11 Dec 2023
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495346
- Sponsor's protocol ID
- 9002
- Acronym
- SomOncoP
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06495346
- Acronym / sponsor ID
- SomOncoP / 9002
- Conditions
- Cell Lung Cancer, Sleep Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 10 Jul 2024 (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.
This exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. This will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population.
This decision tree should help to improve the management of patients with a cancer diagnosis presenting with sleep disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of non-small cell lung cancer followed and treated by the Oncopneumology Department of the Nouvel Hôpital Civil in Strasbourg
Key inclusion criteria (9 listed)
- Patient aged 18 and over.
- Being monitored and treated for non-small cell lung cancer.
- With or without ongoing cancer-specific treatment. With no neurocognitive impairment (MoCA test score ≥26/30).
- With a clinically assessed life expectancy of more than 3 months (Royal Marsden Hospital 0-1) and general health (ECOG <2).
- Able to understand the study documents written in French
Key exclusion criteria (4 listed)
- Patient refusing to take part in the study
- With a mental illness of the psychosis type monitored and treated prior to the study
- Patient under guardianship or curatorship
- Patient under court protection
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 |
|---|---|---|
| self-questionnaires exploringAt each stage, subjects are asked to fill in self-questionnaires exploring the quality of their sleep, their potential distressing symptoms, their psychological state and the quality of their life at that moment. They complete the self-questionnaires at t | Other | – |
Primary outcome
Score sleep quality criteria (Pittsburgh Sleep Quality Index)
Time frame: Every 14 days for 2 months
The overall score ranging from 0 to 21 points. A score of 0 means that there is no difficulty sleeping, and 21 indicates, on the contrary, major difficulties.
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 12 Jun 2026.
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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?
An observational study of Cell Lung Cancer and Sleep Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
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 9 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: finished, as of the sponsor's last update on 12 Jun 2026. 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 France. 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?
Score sleep quality criteria (Pittsburgh Sleep Quality Index) (time frame: Every 14 days for 2 months). 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 12 Jun 2026.