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PERSONAL - Sleep In Breast Cancer | Clinical Trials | Clareo Health

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COMPLETEDNCT05093426

PERSONAL - Sleep In Breast Cancer

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 i...

Lead sponsor: Closed Loop Medicine•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Closed Loop Medicine

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Stage 1:
•Age \> 18 years.
•Informed consent to Stage 1 of the study
•Diagnosis of Stage I, II or III breast cancer within the previous 12 months
•Stage 2:
•Informed consent to Stage 2 of the study
•Current Sleep Disturbance; a score of 8 or more on the Insomnia Severity Index.
•History of sleep disturbance prior to the screening/baseline consultation; with beginning or worsening of sleep disturbance since breast cancer diagnosis e.g. sleep problems began or get worse with the diagnosis of breast cancer or with chemotherapy.
•Possession of a suitable smartphone that participant can use independently.

Exclusion Criteria

•Stage 1:
•Participants who have limited or no understanding of spoken and/or written English.
•Other diagnosis of cancer, not including basal cell carcinoma of the skin or cervical carcinoma in situ, within the previous 5 years
•Stage 2:
•Co-morbidities incompatible with study participation e.g. that result in a participant being unable to complete daily entries satisfactorily via his/her smartphone.
•Known and/or treated sleep apnoea
•Regular shift work or night work (defined as \>1 overnight shift per month)
•Breast feeding

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 3, 2025Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment226

Start dateJan 2022

Last updatedApr 3, 2025

Condition

Insomnia Breast Cancer

Locations shown

Christie NHS Foundation Trust

Manchester

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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