Clinical trial · Observational
Sleep and Immune Checkpoint Inhibitors
Sleep Disturbance and Its Association With Fatigue, Depressive Symptoms, and Clinical Response to Immune Checkpoint Inhibitors (ICI) in Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Sleep disturbances are prevalent in cancer patients and linked to levels of fatigue and depressive symptoms with a major impact on quality of life. A growing body of evidence links sleep disturbances with various health outcomes, including increased risk of depression, cancer, and overall mortality. Inflammation is suggested to be an underlying mechanism both driving and maintaining the symptom cluster of sleep disturbance, fatigue and depressive symptoms, as well as being bi-directionally linked to sleep. The main purpose of the present study is to investigate the prevalence of sleep disturbance and its association with psychological and physical symptoms as well as the clinical response to ICI in non-small-cell lung cancer patients (NSCLC), with a secondary aim of exploring the role of inflammation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical response to treatment
- timeFrame
- Changes from baseline to 9 and 18 weeks after treatment initiation, respectively.
- description
- Radiological evaluation of the clinical response to treatment with ICI, according to RECIST criteria.
Secondary outcomes (21)
- measure
- Insomnia Severity
- timeFrame
- Weekly from baseline to 18 weeks after treatment initiation, and follow-up 1, 2 and 3 years from baseline, respectively.
- description
- Changes in insomnia severity as measured with The Insomnia Severity Index (ISI). Total score ranges from 0 to 28. Interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
- measure
- Sleep diary
- timeFrame
- Baseline, and week 3, 6, 9, 12, 15 and 18, respectively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Confirmed diagnosis of advanced non-small cell lung cancer Exclusion Criteria: * Insufficient Danish proficiency * Pre-existing confounding psychiatric illnesses
References
Publications (1)
- DERIVEDStrom L, Zachariae R, Wu LM, Meldgaard P, Ancoli-Israel S, Lekander M, Mroczek D, Amidi A. Longitudinal investigation of sleep and circadian rest-activity rhythms in non-small cell lung cancer patients during immunotherapy and associations with fatigue, depression, and perceived stress. Sleep Med. 2025 Oct;134:106740. doi: 10.1016/j.sleep.2025.106740. Epub 2025 Aug 10. PMID 40815894