Lung AdenocarcinomaNCT06953492
Sleep State in Lung Cancer: A Retrospective Analysis
An observational study of Lung Adenocarcinoma and Sleep Disorders, Circadian Rhythm, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Lung cancer remains the leading cause of cancer-related mortality globally, with tumor progression closely linked to the immune microenvironment. Sleep disorders (e.g., insomnia, obstructive sleep apnea [OSA]) affect 40-50% of lung cancer patients and may promote tumorigenesis via chronic inflammation, immune… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Lung Adenocarcinoma, Sleep Disorders, Circadian Rhythm
- What is being tested?
- PSQI
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Data source and time range Data source: Adult patients (≥18 years old) diagnosed with primary lung cancer (confirmed by histopathology) in [Zhong Shan Hospital] from January 2018 to January 2025 were retrospectively enrolled. Data extraction: Clinical, pathological and follow-up data were collected through the electronic medical record system (EMR) and the hospital cancer registry database.
Who may be able to join
- NSCLC or SCLC was diagnosed.
- Patients have received immunotherapy (e.g., PD-1/PD-L1 inhibitors) or standard treatment (chemotherapy/radiotherapy).
- Sleep disorder diagnoses and immune-related biomarkers fully recorded in medical records.
Who cannot join
- The patient had a history of other malignant tumors.
- Key clinical data lacking.
- The presence of a serious psychiatric or neurologic condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Sleep State and Lung Cancer Prognosis: a Retrospective Study
Lung cancer remains the leading cause of cancer-related mortality globally, with tumor progression closely linked to the immune microenvironment. Sleep disorders (e.g., insomnia, obstructive sleep apnea [OSA]) affect 40-50% of lung cancer patients and may promote tumorigenesis via chronic inflammation, immune suppression, and metabolic dysregulation. Preclinical and epidemiological studies suggest that chronic sleep deprivation reduces NK cell activity, elevates pro-inflammatory cytokines (IL-6, TNF-α), and upregulates angiogenic factors (VEGF), though clinical evidence remains scarce. This study aims to: Evaluate associations between sleep disorders and immunosuppressive phenotypes (e.g., PD-L1 expression, T-cell exhaustion) in lung cancer patients. Analyze the impact of sleep disturbances on immunotherapy efficacy (e.g., PD-1 inhibitors) and prognostic outcomes. Explore underlying mechanisms, including hypoxia-inducible factor (HIF-1α) signaling and sympathetic nervous system activation
Read the detailed description
Lung cancer is the second most common cancer and the leading cause of cancer-related death in the world, and its treatment and prognosis improvement are still major clinical challenges. In recent years, tumor immunotherapy represented by immune checkpoint inhibitors has significantly improved the survival outcome of some patients, but the individual efficacy varies significantly, suggesting that tumor microenvironment (TME) and host factors (such as lifestyle and metabolic status) may affect the mechanism of immune response. In this context, sleep disorders, as a common accompanying symptom of cancer, have gradually become the focus of research.
The incidence of sleep disorders (such as insomnia and circadian rhythm disturbance) in patients with lung cancer is as high as 40%-70%. Sleep disorders often form symptom clusters with fatigue and pain, which significantly reduce the quality of life and treatment compliance of patients. Studies have shown that sleep disorders not only exacerbate inflammation through neuroendocrine pathways (such as increased cortisol level and inhibited melatonin secretion), but also are closely related to immunosuppression in the tumor microenvironment. For example, sleep deprivation can lead to increased levels of proinflammatory factors (such as IL-6 and TNF-α) in peripheral blood, and inhibit CD8+ T cell function and NK cell activity, thereby weakening the antitumor immune response.
Sleep affects tumor progression by regulating immune cell function and cytokine network. According to the study of the University of Tuebingen in Germany, complete sleep can enhance the activity of T cell integrin and enhance its killing ability against infected or cancerous cells. Sleep disorders can inhibit the function of immune cells and promote tumor immune escape by increasing stress hormones such as adrenaline. In addition, the association between sleep disorders and immunological indicators (such as imbalance of lymphocyte subsets and dynamic changes of PD-L1 expression) during chemotherapy or radiotherapy in lung cancer patients has been partially confirmed, suggesting that sleep disorders may be used as a biomarker to predict the efficacy of immunotherapy.
Although many studies have investigated the effect of sleep disorders on the immune function of cancer patients, the research on the mechanism of lung cancer still has the following shortcomings: (1) Most studies focus on the symptom management of sleep disorders, and lack of systematic analysis of the dynamic relationship between sleep disorders and tumor immune microenvironment; (2) The existing evidence is mostly based on small sample cross-sectional studies, and there is a lack of longitudinal data to support the causal association between sleep disorders and the efficacy of immunotherapy. (3) There is a lack of clinical translational research on whether sleep interventions (e.g., cognitive behavioral therapy, melatonin supplementation) can reverse immunosuppression and enhance treatment response.
Based on the above background, the aim of this study is to investigate the relationship between sleep disorders and lung cancer immune characteristics (such as PD-L1 expression, T cell infiltration) and prognosis of immunotherapy through retrospective analysis, and to provide theoretical basis for optimizing individualized treatment strategies. The results of this study are expected to promote the in-depth analysis of the "sleep-immune" regulatory mechanism, and lay the foundation for a new combined immune therapy integrating sleep management.
- Being tested
- PSQI
- Medical subject headings
- Adenocarcinoma of Lung, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSQIOther
PSQI
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | lung cancer-Non SD; lung cancer-SD Receives: Other: PSQI |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival (OS) : time from immunotherapy initiation to all-cause death
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jan 2018
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953492
- Sponsor's protocol ID
- SD-lung cancer-Retrospective
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 1 May 2025
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sleep State and Lung Cancer Prognosis: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06953492
- Acronym / sponsor ID
- SD-lung cancer-Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 1 May 2025 (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.
Lung cancer remains the leading cause of cancer-related mortality globally, with tumor progression closely linked to the immune microenvironment. Sleep disorders (e.g., insomnia, obstructive sleep apnea [OSA]) affect 40-50% of lung cancer patients and may promote tumorigenesis via chronic inflammation, immune suppression, and metabolic dysregulation. Preclinical and epidemiological studies suggest that chronic sleep deprivation reduces NK cell activity, elevates pro-inflammatory cytokines (IL-6, TNF-α), and upregulates angiogenic factors (VEGF), though clinical evidence remains scarce. This study aims to: Evaluate associations between sleep disorders and immunosuppressive phenotypes (e.g., PD-L1 expression, T-cell exhaustion) in lung cancer patients. Analyze the impact of sleep disturbances on immunotherapy efficacy (e.g., PD-1 inhibitors) and prognostic outcomes. Explore underlying mechanisms, including hypoxia-inducible factor (HIF-1α) signaling and sympathetic nervous system activation
Detailed description
Lung cancer is the second most common cancer and the leading cause of cancer-related death in the world, and its treatment and prognosis improvement are still major clinical challenges. In recent years, tumor immunotherapy represented by immune checkpoint inhibitors has significantly improved the survival outcome of some patients, but the individual efficacy varies significantly, suggesting that tumor microenvironment (TME) and host factors (such as lifestyle and metabolic status) may affect the mechanism of immune response. In this context, sleep disorders, as a common accompanying symptom of cancer, have gradually become the focus of research.
The incidence of sleep disorders (such as insomnia and circadian rhythm disturbance) in patients with lung cancer is as high as 40%-70%. Sleep disorders often form symptom clusters with fatigue and pain, which significantly reduce the quality of life and treatment compliance of patients. Studies have shown that sleep disorders not only exacerbate inflammation through neuroendocrine pathways (such as increased cortisol level and inhibited melatonin secretion), but also are closely related to immunosuppression in the tumor microenvironment. For example, sleep deprivation can lead to increased levels of proinflammatory factors (such as IL-6 and TNF-α) in peripheral blood, and inhibit CD8+ T cell function and NK cell activity, thereby weakening the antitumor immune response.
Sleep affects tumor progression by regulating immune cell function and cytokine network. According to the study of the University of Tuebingen in Germany, complete sleep can enhance the activity of T cell integrin and enhance its killing ability against infected or cancerous cells. Sleep disorders can inhibit the function of immune cells and promote tumor immune escape by increasing stress hormones such as adrenaline. In addition, the association between sleep disorders and immunological indicators (such as imbalance of lymphocyte subsets and dynamic changes of PD-L1 expression) during chemotherapy or radiotherapy in lung cancer patients has been partially confirmed, suggesting that sleep disorders may be used as a biomarker to predict the efficacy of immunotherapy.
Although many studies have investigated the effect of sleep disorders on the immune function of cancer patients, the research on the mechanism of lung cancer still has the following shortcomings: (1) Most studies focus on the symptom management of sleep disorders, and lack of systematic analysis of the dynamic relationship between sleep disorders and tumor immune microenvironment; (2) The existing evidence is mostly based on small sample cross-sectional studies, and there is a lack of longitudinal data to support the causal association between sleep disorders and the efficacy of immunotherapy. (3) There is a lack of clinical translational research on whether sleep interventions (e.g., cognitive behavioral therapy, melatonin supplementation) can reverse immunosuppression and enhance treatment response.
Based on the above background, the aim of this study is to investigate the relationship between sleep disorders and lung cancer immune characteristics (such as PD-L1 expression, T cell infiltration) and prognosis of immunotherapy through retrospective analysis, and to provide theoretical basis for optimizing individualized treatment strategies. The results of this study are expected to promote the in-depth analysis of the "sleep-immune" regulatory mechanism, and lay the foundation for a new combined immune therapy integrating sleep management.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Other: PSQIlung cancer-Non SD; lung cancer-SD |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Data source and time range Data source: Adult patients (≥18 years old) diagnosed with primary lung cancer (confirmed by histopathology) in [Zhong Shan Hospital] from January 2018 to January 2025 were retrospectively enrolled. Data extraction: Clinical, pathological and follow-up data were collected through the electronic medical record system (EMR) and the hospital cancer registry database.
Key inclusion criteria (3 listed)
- NSCLC or SCLC was diagnosed.
- Patients have received immunotherapy (e.g., PD-1/PD-L1 inhibitors) or standard treatment (chemotherapy/radiotherapy).
- Sleep disorder diagnoses and immune-related biomarkers fully recorded in medical records.
Key exclusion criteria (3 listed)
- The patient had a history of other malignant tumors.
- Key clinical data lacking.
- The presence of a serious psychiatric or neurologic condition.
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 |
|---|---|---|
| PSQIPSQI | Other | Lung cancer |
Primary outcome
OS
Time frame: Baseline
Overall survival (OS) : time from immunotherapy initiation to all-cause death
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 1 May 2025.
- 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.
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 Lung Adenocarcinoma and Sleep Disorders, Circadian Rhythm, run by Shanghai Zhongshan Hospital at 1 site in China.
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 3 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 1 May 2025. 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 China. 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?
OS (time frame: Baseline). 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 1 May 2025.