SleepXacT (CPMS 58351 , IRAS 333820)

UPDATED - 04/08/2025

This study is a multi-centre (location), single-arm, feasibility study of using contactless sleep technology for objective measurement of sleep in dementia or mild cognitive impairment. Patient participants in primary care (people living with dementia or mild cognitive impairment [PLWD/MCI], with experience of poor sleep or interested in improving their sleep) and their carers (family members, friends or spouses, or paid professional carers, such as care home staff), will be recruited in pairs (dyads).

All participants will be invited to complete baseline assessments and follow-up assessments at 9 and 15 weeks, from the date of their Baseline Assessment. All participants will be offered the intervention, which involves a tailored care-plan to improve sleep that is co-created by the patient, their carer, and GP. No long-term follow-up is planned.

The objective measurement of the PLWD/MCI participant’s sleep will be fully coordinated by the SleepXacT study team, based at the University of East Anglia in Norwich, Norfolk. Using a bedside sleep tracker, the team will liaise directly with the recruited patient-carer dyads to arrange device delivery and provide support with setup in the participant’s home or care home. NHS site staff will not be required to assist with this aspect of the study.

To assess the acceptability and practicality of the objective sleep measurement in PLWD/MCI, carer participants will take part in a semi-structured interview, and healthcare professionals will be invited to optionally complete an online survey and/or take part in an optional online focus group meeting.

These qualitative processes aim to understand adherence to and engagement with the study procedures, experiences with using the sleep tracker, and the contrast between subjective and objective sleep assessment. We will also evaluate the sufficiency of resources for conducting objective sleep measures alongside the TIMES intervention, the ease of collecting and analysing objective sleep data, and the usefulness of this data in clinical decision-making.

Objective A: Assess the feasibility of collecting and analysing objective sleep quality data using a contactless sleep tracker in patients living with dementia or mild cognitive impairment.

Objective B: Understand the experiences of carers in using contactless sleep technology with the person they care for. 

Objective C: Understand the views of the GPs on the usefulness of the objective sleep information from the contactless sleep tracker in assessing sleep and planning tailored care for individuals living with dementia or mild cognitive impairment.

Inclusion criteria: Patient participants (PLWD/MCI)

1. Aged >18 years

2. Clinical diagnosis of dementia/MCI of any subtype and stage 

3. In primary care and registered with a participating general practice

4. Residing at home or in a community care home in England 

5. Has poor sleep of any type or has expressed an interest in improving their sleep, as indicated by the PLWD/MCI, their family or carer

6. Have a family or professional carer who provides support at least one hour per week and is willing to solely assist with completion of outcomes

7. Able to understand and communicate in spoken and written English well enough to complete the outcome measures and questionnaires 

8. Has capacity to provide informed consent OR has a personal or nominated consultee who is able to provide the opinion that the PLWD/MCI would have no objection to taking part in the study

Inclusion criteria: Carer participants 

1. Aged >18 years

2. Resides in England

3. Able to understand and communicate in spoken and written English well enough to complete the outcome measures and questionnaires 

4. Has capacity to provide informed consent

5. Has lived- or professional-experience of poor sleep in the PLWD/MCI who they provide care for, or has noted an interest from the PLWD/MCI in improving their sleep

6. Is not already enrolled in the study with another patient participant (each carer participant can only take part once)

7. Patient participant residence (at home or in a community care home) offers physical space at the bedside for the positioning of the contactless sleep tracker device  

Exclusion criteria: Patient participants (PLWD/MCI)

1. Deemed overburdened or has severe unstable (mental or physical) health problems

2. Unable to communicate (in English) even with augmentative and alternative communication support 

3. Does not have a family or professional carer

4. Undergoing end of life care 

5. Planned unavailability for >3 weeks during intervention and follow-up (i.e., approximately next 4 months)

6. Carer is unable and/or unwilling to handle (e.g., switch on and off) the sleep tracker device or its associated materials

Exclusion criteria: Carer participants 

1. Deemed overburdened or has severe unstable (mental or physical) health problems

2. Diagnosis or health condition that may impair their ability to complete outcome assessments, as determined by the carer

3. Planned unavailability for >3 weeks during intervention and follow-up (i.e., approximately next 4 months)

4. Unavailability or unwillingness to participate in a semi-structured interview assessing the lived experience of using the sleep tracker.

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

EMIS: Jodie Button – jodie.button@nihr.ac.uk 

SystmOne: James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

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