CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 226 enrolled
Drug / intervention
Stage 2 Digital sleep diary appother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05093426
NCT05093426N/ACompleted

Personalised Electronic Record Supported Two-Stage Observational Study of Sleep in Patients With Breast Cancer

Closed Loop Medicine·observational·Posted Oct 26, 2021·Updated Apr 3, 2025

In Brief

An observational study evaluating Stage 2 Digital sleep diary app for Insomnia and Breast Cancer. Completed, enrolled 226 participants across 1 site.

Detailed Summary

Sleep is essential for human function, immunity, and well-being. In the general population, sleep disturbance and insomnia cause significant health problems and impact on the quality of life of many individuals. The incidence of insomnia in cancer patients is disproportionality higher, with breast cancer patients experiencing prevalence rates ranging from 19% to 69%. The impact of insomnia on cancer patients' lives can be significant and is associated with depression, cancer-related fatigue, increased pain, reduced quality of life, decreased immunity, disease progression, and survival. To date, breast cancer studies show large variation in reported insomnia prevalence rates, and the severity of sleep complaints in these patients have been difficult to assess. Thus, these issues require further investigation using standardised and validated measures. In this observational study, we aim to investigate the prevalence and severity of insomnia in a cohort of breast cancer patients at the Christie Hospital using the Insomnia Severity Index (ISI), a validated measure for insomnia. This study will consist of two stages. In Stage 1, patients aged 18 and over, who provide informed consent and have a diagnosis of Stage I, II or III breast cancer in the previous 12 months will be asked to complete the validated ISI. Using the ISI, participants identified as having sleeping difficulties and/or insomnia will be invited to Stage 2 of the study. In this stage, participants will be asked to track their sleep each morning for 3 weeks using a digital sleep diary downloaded onto their own smartphone. They will also be asked to complete a series of questionnaires gathering information regarding their quality of life, well-being, and health. This research will provide a better understanding of sleeping patterns, sleeping difficulties and insomnia in patients with breast cancer, and in the long-term, help us design better treatments for patients with sleeping problems.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 26, 2021
Enrollment StartJan 15, 2022
Primary CompletionJun 30, 2022
Study CompletionAug 3, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.7 years ago

Interventions

Stage 2 Digital sleep diary appother

Participants in Stage 2 will be asked to download a digital sleep diary app and complete a sleep log every day for 21 days.