InsomniaNCT05093426
PERSONAL - Sleep In Breast Cancer
An observational study of Insomnia and Breast Cancer, run by Closed Loop Medicine at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Breast Cancer
- What is being tested?
- Stage 2 Digital sleep diary app
- How many people
- 226 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2022to 3 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of patients diagnosed with breast cancer in the United Kingdom.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalised Electronic Record Supported Two-Stage Observational Study of Sleep in Patients With 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 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.
- Conditions
- Insomnia, Breast Cancer
- Being tested
- Stage 2 Digital sleep diary app
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Insomnia in Breast cancer cohort | A single cohort will be observed in Stage 1 to assess the prevalence of insomnia suffered by participants who suffer from breast cancer. A subset of participants will continue to Stage 2 to use a digital sleep diary app for an observational period of 3 weeks. Receives: Other: Stage 2 Digital sleep diary app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Insomnia in a Cohort of Breast Cancer Patients
Percentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index
Measured: 3 weeks
Secondary outcomes (7)
In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Insomnia Severity Over a Three-week Period.
Insomnia severity using Insomnia Severity Index (min. 0, max. 28 where higher scores mean a worse outcome). With severity classified by total score for the Insomnia Severity Index: 0-7 no significant insomnia, 8-14 Subthreshold insomnia, 15-21 Clinical insomnia (moderate severity) and 22-28 Clinical Insomnia (Severe severity)
Measured: 2 weeks
In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Sleep Efficiency Over a Three-week Period.
In patients with breast cancer experiencing insomnia (defined as score of 8 or more on the Insomnia Severity Index; ISI scale), to assess Sleep efficiency over a three-week period. Sleep efficiency (the % of time a participant is asleep whilst in bed) measured using Sleep diary (derived from total time asleep relative to total time in bed).
Measured: 3 weeks
In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Quality of Life Over a Three-week Period.
Quality of Life using EQ-5D-5L questionnaire (multiple choice questions regarding Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression as well as measure of % of health using scale where higher percentage is greater outcome) and Functional Assessment of Cancer Therapy - Endocrine Systems questionnaire (questions regarding Physical well-being, Social/Family well-being, Emotional, Functional well-being and Additional concerns using scale of 0 - 4 where 0 is Not at all, 1 is A little bit, 2 is Some-what, 3 is Quite a bit and 4 is Very much).
Measured: 3 weeks
In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Quality of Life Over a Three-week Period.
EQ-5D-5L questionnaire: multiple choice questions for Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression and % of health where a higher % is a greater outcome). Functional Assessment of Cancer Therapy - Endocrine Systems (FACT-ES) (sub-scales: Physical well-being, Social/Family well-being, Emotional, Functional well-being and Endocrine symptoms): each question in sub-scales are scored using a scale of 0-4 where 0 is Not at all, 1 is A little bit, 2 is Some-what, 3 is Quite a bit and 4 is Very much. Scores for questions are added to give total baseline and total day 21 score for each sub-scale. Minimum total score is 0 for all sub-scales, the maximum scores are 28 for Physical, Social/Family and Functional well-being sub-scales, 24 for the Emotional well-being sub-scale, 76 for Endocrine symptoms. A lower total score represents better outcomes. FACT-ES = Total of subscale scores (0-184). FACT-G = Total of subscale scores excluding endocrine system (0-108).
Measured: 3 weeks
To Assess: - Compliance of Data Entry Into the Digital Sleep Diary - Feasibility and Experience of Patients to Input Data Relating to Their Sleep Into a Mobile Phone Application Daily
Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire.
Measured: 3 weeks
Associations Between Insomnia Prevalence and Severity as Measured by the Insomnia Severity Index and Quality of Life (EQ-5D-5L and FACT-ES) With Clinical or Treatment Characteristics of Breast Cancer Patients.
Assessment to determine if there is any association or correlation between insomnia prevalence and severity as well as quality of life (using insomnia severity index and EQ-5D-5L and Functional Assessment of Cancer Therapy - Endocrine Systems questionnaires) for patients in subgroups based on clinical or treatment characteristics i.e. breast cancer stage (Stage I, II or III), tumour staging (T1, T2, T3 or DCIS) treatment regimen (Systemic treatment, Dexamethasone treatment, Radiation therapy, Hormonal or Targeted Therapy as well as time since start of chemotherapy and current systemic anti-cancer therapy).
Measured: 3 weeks
Safety of the Digital Sleep Diary
Adverse Events and Serious Adverse Events will be collected and summarised.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start15 Jan 2022
- Primary completion30 Jun 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Closed Loop Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Armstrong, PhD, MRCP, MBChB, BSc(Hons), Principal investigator, Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093426
- Sponsor's protocol ID
- CLM-INS-004
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2021
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be confirmed whether the individual participant data will be shared
Publications
Ruel S, Ivers H, Savard MH, Gouin JP, Lemieux J, Provencher L, Caplette-Gingras A, Bastien C, Morin CM, Couture F, Savard J. Insomnia, immunity, and infections in cancer patients: Results from a longitudinal study. Health Psychol. 2020 May;39(5):358-369. doi: 10.1037/hea0000811. Epub 2019 Dec 19.
PubMed 31855038Kwak A, Jacobs J, Haggett D, Jimenez R, Peppercorn J. Evaluation and management of insomnia in women with breast cancer. Breast Cancer Res Treat. 2020 Jun;181(2):269-277. doi: 10.1007/s10549-020-05635-0. Epub 2020 Apr 20.
PubMed 32314110Fleming L, Randell K, Stewart E, Espie CA, Morrison DS, Lawless C, Paul J. Insomnia in breast cancer: a prospective observational study. Sleep. 2019 Mar 1;42(3):zsy245. doi: 10.1093/sleep/zsy245.
PubMed 30521041Fontes F, Pereira S, Costa AR, Goncalves M, Lunet N. The impact of breast cancer treatments on sleep quality 1 year after cancer diagnosis. Support Care Cancer. 2017 Nov;25(11):3529-3536. doi: 10.1007/s00520-017-3777-6. Epub 2017 Jun 16.
PubMed 28623402Fortner BV, Stepanski EJ, Wang SC, Kasprowicz S, Durrence HH. Sleep and quality of life in breast cancer patients. J Pain Symptom Manage. 2002 Nov;24(5):471-80. doi: 10.1016/s0885-3924(02)00500-6.
PubMed 12547047Hajj A, Hachem R, Khoury R, Nehme T, Hallit S, Nasr F, Karak FE, Chahine G, Kattan J, Khabbaz LR. Clinical and Genetic Factors Associated With the Breast Cancer-Related Sleep Disorders: The "CAGE-Sleep" Study-A Cross-Sectional Study. J Pain Symptom Manage. 2021 Sep;62(3):e46-e55. doi: 10.1016/j.jpainsymman.2021.02.022. Epub 2021 Feb 22.
PubMed 33631331Savard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8.
PubMed 21825267Brzecka A, Sarul K, Dyla T, Avila-Rodriguez M, Cabezas-Perez R, Chubarev VN, Minyaeva NN, Klochkov SG, Neganova ME, Mikhaleva LM, Somasundaram SG, Kirkland CE, Tarasov VV, Aliev G. The Association of Sleep Disorders, Obesity and Sleep-Related Hypoxia with Cancer. Curr Genomics. 2020 Sep;21(6):444-453. doi: 10.2174/1389202921999200403151720.
PubMed 33093806Palesh O, Aldridge-Gerry A, Zeitzer JM, Koopman C, Neri E, Giese-Davis J, Jo B, Kraemer H, Nouriani B, Spiegel D. Actigraphy-measured sleep disruption as a predictor of survival among women with advanced breast cancer. Sleep. 2014 May 1;37(5):837-42. doi: 10.5665/sleep.3642.
PubMed 24790261Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol. 2001 Feb 1;19(3):895-908. doi: 10.1200/JCO.2001.19.3.895.
PubMed 11157043Marion LP, Ivers H, Savard J. Feasibility of a Preventive Intervention for Insomnia in Women with Breast Cancer Receiving Chemotherapy. Behav Sleep Med. 2021 Jan-Feb;19(1):70-82. doi: 10.1080/15402002.2019.1707203. Epub 2019 Dec 24.
PubMed 31873040O'Donnell JF. Insomnia in cancer patients. Clin Cornerstone. 2004;6 Suppl 1D:S6-14. doi: 10.1016/s1098-3597(05)80002-x.
PubMed 15675652Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
PubMed 22294820Horsch CH, Lancee J, Griffioen-Both F, Spruit S, Fitrianie S, Neerincx MA, Beun RJ, Brinkman WP. Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial. J Med Internet Res. 2017 Apr 11;19(4):e70. doi: 10.2196/jmir.6524.
PubMed 28400355
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Electronic Record Supported Two-Stage Observational Study of Sleep in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05093426
- Acronym / sponsor ID
- CLM-INS-004
- Conditions
- Insomnia, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Closed Loop MedicineIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insomnia in Breast cancer cohort | – | Other: Stage 2 Digital sleep diary appA single cohort will be observed in Stage 1 to assess the prevalence of insomnia suffered by participants who suffer from breast cancer. A subset of participants will continue to Stage 2 to use a digital sleep diary app for an observational period of 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of patients diagnosed with breast cancer in the United Kingdom.
Key inclusion criteria (9 listed)
- 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
- Informed consent to Stage 2 of the study
- Current Sleep Disturbance; a score of 8 or more on the Insomnia Severity Index.
Key exclusion criteria (8 listed)
- 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
- 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)
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 |
|---|---|---|
| Stage 2 Digital sleep diary appParticipants in Stage 2 will be asked to download a digital sleep diary app and complete a sleep log every day for 21 days. | Other | Insomnia in Breast cancer cohort |
Primary outcome
Prevalence of Insomnia in a Cohort of Breast Cancer Patients
Time frame: 3 weeks
Percentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index
7 secondary outcomes
In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Insomnia Severity Over a Three-week Period.
Time frame: 2 weeks
In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Sleep Efficiency Over a Three-week Period.
Time frame: 3 weeks
In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Quality of Life Over a Three-week Period.
Time frame: 3 weeks
In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Quality of Life Over a Three-week Period.
Time frame: 3 weeks
To Assess: - Compliance of Data Entry Into the Digital Sleep Diary - Feasibility and Experience of Patients to Input Data Relating to Their Sleep Into a Mobile Phone Application Daily
Time frame: 3 weeks
Associations Between Insomnia Prevalence and Severity as Measured by the Insomnia Severity Index and Quality of Life (EQ-5D-5L and FACT-ES) With Clinical or Treatment Characteristics of Breast Cancer Patients.
Time frame: 3 weeks
Safety of the Digital Sleep Diary
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31855038Ruel S, Ivers H, Savard MH, Gouin JP, Lemieux J, Provencher L, Caplette-Gingras A, Bastien C, Morin CM, Couture F, Savard J. Insomnia, immunity, and infections in cancer patients: Results from a longitudinal study. Health Psychol. 2020 May;39(5):358-369. doi: 10.1037/hea0000811. Epub 2019 Dec 19.
- Background: PubMed 32314110Kwak A, Jacobs J, Haggett D, Jimenez R, Peppercorn J. Evaluation and management of insomnia in women with breast cancer. Breast Cancer Res Treat. 2020 Jun;181(2):269-277. doi: 10.1007/s10549-020-05635-0. Epub 2020 Apr 20.
- Background: PubMed 30521041Fleming L, Randell K, Stewart E, Espie CA, Morrison DS, Lawless C, Paul J. Insomnia in breast cancer: a prospective observational study. Sleep. 2019 Mar 1;42(3):zsy245. doi: 10.1093/sleep/zsy245.
- Background: PubMed 28623402Fontes F, Pereira S, Costa AR, Goncalves M, Lunet N. The impact of breast cancer treatments on sleep quality 1 year after cancer diagnosis. Support Care Cancer. 2017 Nov;25(11):3529-3536. doi: 10.1007/s00520-017-3777-6. Epub 2017 Jun 16.
- Background: PubMed 12547047Fortner BV, Stepanski EJ, Wang SC, Kasprowicz S, Durrence HH. Sleep and quality of life in breast cancer patients. J Pain Symptom Manage. 2002 Nov;24(5):471-80. doi: 10.1016/s0885-3924(02)00500-6.
- Background: PubMed 33631331Hajj A, Hachem R, Khoury R, Nehme T, Hallit S, Nasr F, Karak FE, Chahine G, Kattan J, Khabbaz LR. Clinical and Genetic Factors Associated With the Breast Cancer-Related Sleep Disorders: The "CAGE-Sleep" Study-A Cross-Sectional Study. J Pain Symptom Manage. 2021 Sep;62(3):e46-e55. doi: 10.1016/j.jpainsymman.2021.02.022. Epub 2021 Feb 22.
- Background: PubMed 21825267Savard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8.
- Background: PubMed 33093806Brzecka A, Sarul K, Dyla T, Avila-Rodriguez M, Cabezas-Perez R, Chubarev VN, Minyaeva NN, Klochkov SG, Neganova ME, Mikhaleva LM, Somasundaram SG, Kirkland CE, Tarasov VV, Aliev G. The Association of Sleep Disorders, Obesity and Sleep-Related Hypoxia with Cancer. Curr Genomics. 2020 Sep;21(6):444-453. doi: 10.2174/1389202921999200403151720.
- Background: PubMed 24790261Palesh O, Aldridge-Gerry A, Zeitzer JM, Koopman C, Neri E, Giese-Davis J, Jo B, Kraemer H, Nouriani B, Spiegel D. Actigraphy-measured sleep disruption as a predictor of survival among women with advanced breast cancer. Sleep. 2014 May 1;37(5):837-42. doi: 10.5665/sleep.3642.
- Background: PubMed 11157043Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol. 2001 Feb 1;19(3):895-908. doi: 10.1200/JCO.2001.19.3.895.
- Background: PubMed 31873040Marion LP, Ivers H, Savard J. Feasibility of a Preventive Intervention for Insomnia in Women with Breast Cancer Receiving Chemotherapy. Behav Sleep Med. 2021 Jan-Feb;19(1):70-82. doi: 10.1080/15402002.2019.1707203. Epub 2019 Dec 24.
- Background: PubMed 15675652O'Donnell JF. Insomnia in cancer patients. Clin Cornerstone. 2004;6 Suppl 1D:S6-14. doi: 10.1016/s1098-3597(05)80002-x.
- Epidemiology of Insomnia - Prevalence, Course, Risk Factors, and Public Health BurdenLink provided by the sponsor.
- Insomnia in breast cancer: prevalence and associated factorsLink provided by the sponsor.
- Disruption of sleep, sleep-wake activity rhythm, and nocturnal melatonin production in breast cancer patients undergoing adjuvant chemotherapy: a prospective cohort studyLink provided by the sponsor.
- Joint statement on seeking consent by electronic methodsLink provided by the sponsor.
- Consent and Participant Information GuidanceLink provided by the sponsor.
- Sample Size Calculator for Estimating a Single ProportionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To be confirmed whether the individual participant data will be shared
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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.
Anne Armstrong, PhD, MRCP, MBChB, BSc(Hons) principal investigator
Christie NHS Foundation Trust
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 Insomnia and Breast Cancer, run by Closed Loop Medicine at 1 site in United Kingdom.
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 9 inclusion and 8 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 3 Apr 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence of Insomnia in a Cohort of Breast Cancer Patients (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05093426, which also lists 18 linked publications.
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 3 Apr 2025.