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Trial Title:
INvestigating the Value of Early Sleep Therapy
NCT ID:
NCT06294041
Condition:
Acute Insomnia (Disorder)
Conditions: Official terms:
Sleep Initiation and Maintenance Disorders
Conditions: Keywords:
acute insomnia
breast cancer
prehabilitation
sleep restriction therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Single (Outcomes Assessor)
Masking description:
Due to the nature of the SRT intervention, the research nurse, patients and most of the
study team cannot be blinded to treatment allocation. However, the statistician will be
blinded to treatment allocation (i.e., SRT or SHE) until after analysis is complete
Intervention:
Intervention type:
Behavioral
Intervention name:
Sleep Restriction Therapy (SRT)
Description:
SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active
ingredient within multi-component CBT-I. Our SRT protocol involves standardising and
(where required) limiting a patient's time in bed with the aim of increasing homeostatic
sleep pressure, over-riding cognitive and physiological arousal, and strengthening
circadian control of sleep. Those randomised to the SRT arm will receive two online
sessions supported by two telephone calls over a 4-week intervention phase. The
intervention will be delivered by trained research nurses
Arm group label:
Sleep Restriction Therapy (SRT)
Intervention type:
Behavioral
Intervention name:
Sleep Hygiene Education (SHE)
Description:
SHE will be delivered via a booklet that provides information about lifestyle changes
(e.g., reducing exercise in the evening, light snack before bedtime, reducing caffeine)
and changes to the bedroom environment (e.g., dark room, comfortable mattress, optimal
room temperature). Patients in the SHE condition will be instructed to implement the SHE
advice over a 4-week period. One week after randomisation to SHE, the RA will telephone
patients to check they understand the SHE advice and answer any questions they may have.
SHE has successfully been used as a control condition in other trials evaluating SRT and
does not have any therapeutic benefit for individuals with insomnia but is often part of
usual care, so is a credible alternative to SRT.
Arm group label:
Sleep Hygiene Education
Summary:
Twenty percent of breast cancer survivors have insomnia, which is defined as persistent
trouble falling and/or staying asleep that results in difficulty functioning during the
day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer
treatment, and continue into cancer survivorship. Insomnia interferes with daily
activities and may cause other mental and physical health problems. It also makes it more
difficult to cope with cancer treatment and makes recovery more challenging. For these
reasons, it is important to address early signs of sleep problems in cancer patients by
offering interventions that may prevent the development of insomnia.
Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep
by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction
Therapy has been used successfully to treat chronic insomnia in breast cancer survivors
who have completed cancer treatment. However, it has never been tested on newly diagnosed
breast cancer patients with early signs of sleep disturbance, who are undergoing cancer
treatment.
This study will address this knowledge gap by randomly assigning newly diagnosed patients
with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education
(SHE) control intervention. The study will assess sleep and mental health before and
after both interventions to determine how feasible and acceptable Sleep Restriction
Therapy is to patients and to plan for a future, larger study. Throughout, the
investigators will work with patients with lived experience of breast cancer and poor
sleep to ensure our study is informed by their expertise.
Detailed description:
The primary aim of this project is to assess the feasibility and inform the design of a
full-scale RCT of SRT for newly diagnosed breast cancer patients with acute insomnia.
Secondary aims of this project are to assess the effects of SRT alongside a sleep hygiene
education (SHE) control on sleep, rest-activity rhythms, and mental health.
Participants will be recruited from breast cancer results clinics in two study sites. Our
target population is newly diagnosed, non-metastatic patients whose primary cancer
treatment is surgery. Participants will go through initial screening and will be sent an
online participant information sheet and consent form. Once consent form is signed,
marking enrolment in the study, the second stage of screening will commence. It involves
assessing current sleep status (based on diagnostic criteria for acute insomnia) current
psychiatric symptoms and review of other relevant medical information (diagnosis of other
sleep disorders, other medical and psychiatric disorders). This is to confirm the
diagnosis of acute insomnia and establish that there are no medical or psychiatric
conditions that might preclude someone from taking part in the study. Once eligibility is
ascertained, patients will be randomly assigned to SRT or the SHE control group. The
investigators aim to randomise 50 patients (n=25 in each trial arm).
After randomisation to SRT or SHE, patients will be sent an email with a link to complete
a baseline (pre-intervention) assessment of sleep, fatigue, and mental health. Patients
will also be required to complete the consensus sleep diary and wear an actigraphy device
for 7 days prior to commencement of SRT/SHE to record sleep and rest/activity rhythms.
After completion of the baseline assessment, patients will either be referred to the
research nurse for commencement of the SRT protocol or provided with the SHE resource. At
6 weeks, and 3 months post-randomisation, patients will be requested to complete the same
battery of questionnaires as during the baseline assessment. Following completion of the
final study assessment (3 months post-randomisation), those randomised to the SHE
condition will be offered the opportunity to complete the SRT protocol without the
requirement to complete any further assessments.
Interventions: Sleep Restriction Therapy (SRT)
SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active
ingredient within multi-component CBT-I. Those randomised to the SRT arm will receive two
online sessions supported by two telephone calls over a 4-week intervention phase. SRT
will be delivered by trained research nurses.
Sleep Hygiene Education (SHE)
SHE will be delivered via a booklet that provides information about lifestyle changes
(e.g., reducing exercise in the evening, light snack before bedtime, reducing caffeine)
and changes to the bedroom environment (e.g., dark room, comfortable mattress, optimal
room temperature). Patients in the SHE condition will be instructed to implement the SHE
advice over a 4-week period.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Participant is willing and able to give informed consent
Aged 18 years and above
Screen positive for acute insomnia, defined as dissatisfaction with sleep quality or
duration, accompanied by other night / daytime symptoms, present for between 2 weeks and
3 months
Newly diagnosed with non-metastatic breast cancer
Primary cancer treatment is surgery
Exclusion Criteria:
- Main study exclusion criteria are limited to conditions contraindicated for SRT or
factors that would preclude implementation of SRT.
1. Pregnancy
2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive
sleep apnoea, narcolepsy) or screen "positive" for additional sleep disorder at
study screening interview
3. Dementia / Mild Cognitive Impairment
4. Epilepsy
5. Psychosis (schizophrenia, bipolar disorder)
6. Current suicidal ideation with intent or attempted suicide within past 2 months
7. Night, evening, early morning, or rotating shiftwork
8. Current / previous psychological treatment for insomnia during the last 12
months
9. Chemotherapy and / or radiotherapy commenced
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
June 1, 2025
Lead sponsor:
Agency:
University of Strathclyde
Agency class:
Other
Collaborator:
Agency:
University of Oxford
Agency class:
Other
Collaborator:
Agency:
University of Glasgow
Agency class:
Other
Collaborator:
Agency:
NHS Greater Glasgow and Clyde
Agency class:
Other
Collaborator:
Agency:
NHS Grampian
Agency class:
Other
Source:
University of Strathclyde
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06294041