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Search / Trial NCT07068971

Sleep Well At Night

Launched by OUR LADY'S HOSPICE AND CARE SERVICES · Jul 7, 2025

Trial Information

Current as of October 02, 2025

Enrolling by invitation

Keywords

Non Pharmacological Multimodal Interventional Feasibility Study Advanced Cancer

ClinConnect Summary

This study, called Sleep Well At Night (SWAN), is a feasibility test of a non-drug, multi-component approach to help sleep disturbances in adults with advanced cancer. It uses three parts: an online cognitive behavioral therapy program for insomnia (CBT-I), daily bright light therapy in the morning, and an individualized plan to increase daytime activity. The study will take place over 8 weeks and includes baseline and final assessments, plus weekly check-ins. Participants will wear a watch to track sleep and activity and keep a sleep diary, with some readings collected in the first and last weeks.

If you are eligible, you would be 18 or older, have a diagnosis of advanced cancer, report sleep problems, score 5 or more on a sleep questionnaire, and be able to participate as an outpatient with enough health to take part (ECOG 1–3, prognosis over 3 months). The trial aims to recruit about 30 people and does not test a drug or device for approval. The main goals are to see how feasible and acceptable this approach is—how many people join, stay in the study, complete the intervention, and what they think about it—while also looking at sleep quality and physical symptoms as secondary outcomes. The study is run in Dublin at Our Lady’s Hospice and Care Services, led by Prof. Andrew Davies.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 18 years old and over
  • 2. Diagnosis of advanced cancer (locally advanced, metastatic)
  • 3. Subjective sleep disturbance
  • 4. Total score of 5 or more on PSQI
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status 1-3
  • 6. Attending outpatients (oncology and/or palliative care)
  • 7. Estimated prognosis of \> 3 months
  • Exclusion Criteria:
  • 1. Inpatient
  • 2. ECOG performance status 4
  • 3. Cognitive impairment limiting the ability to complete assessment tools and sleep diary
  • 4. Engaged in shift work
  • 5. A recent exacerbation of symptoms (e.g. pain/nausea/dyspnoea) which may impact sleep
  • 6. History of uncontrolled mania or bipolar disorder
  • 7. Recent history or current thoughts of self-harm or suicide
  • 8. Recent change in antidepressant medication

About Our Lady's Hospice And Care Services

Our Lady's Hospice and Care Services is a leading healthcare provider dedicated to delivering exceptional palliative and end-of-life care. With a commitment to enhancing the quality of life for patients and their families, the organization integrates compassionate clinical support with innovative research initiatives. By sponsoring clinical trials, Our Lady's Hospice aims to advance medical knowledge and improve therapeutic options in palliative care, ensuring that patients receive the most effective treatments tailored to their individual needs. Through collaboration with healthcare professionals and research institutions, the organization strives to foster a holistic approach to care that prioritizes dignity, comfort, and well-being.

Locations

Dublin, Ireland

Patients applied

0 patients applied

Trial Officials

Professor Andrew Davies

Principal Investigator

Our Lady's Hospice & Care Services

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported