Feasibility and practicability of low-burden contactless sleep tracking devices to measure objective sleep quality in sleep interventions in patients with dementia and mild cognitive impairment (SleepXacT)

Sleep problems are common in people living with dementia (PLWD), with a suggested bidirectional relationship with neurodegeneration. Sleep is also critical for quality of life and mental well-being.

Sleep problems in PLWD often represent the breaking point at which carers already experiencing remarkable pressures from day-to-day caregiving become unable to further cope, leading to the transition of PLWD to care homes.

Therefore, addressing sleep problems is critical for slowing the disease process and protecting the quality of life of both the patients and their families. Unfortunately, sleep problems in PLWD are complex and require individually tailored interventions.

The NIHR TIMES clinical decision support tool aims to address sleep problems in PLWD, with extensive validation and optimization planned in the TIMES trial.

However, TIMES does not currently include objective biomarkers of sleep quality and testing of this clinical decision tool is based on carer reports only.

Subjective reports are proxy measures of sleep quality, that can have limited validity in characterising patients s sleep quality. This is because carers may not always be available, or able, to assess and report sleep problems of PLWD.

Carers are also often overburdened, may find it difficult to assess the sleep quality of PLWD, and may struggle to provide regular reports to health practitioners. This would be required by the tailored intervention process of TIMES. If feasible and acceptable, objective sleep measurement may improve clinical decisions and patient outcomes.

We hypothesize that supplementing or even replacing the subjective reports with objective sleep measures in the future may help overcome the potential limitations of TIMES and increase its efficacy as well as applicability for patients living in care homes or on their own, without a paid or unpaid carer.

We propose a single-arm feasibility study (SleepXact) to test the practicality, and acceptability of a contactless sleep tracker to provide objective sleep characterization in PLWD. This will be accomplished simultaneously with the NIHR TIMES feasibility trial (WP3).

A group of 40 participants will be enrolled into SleepXact following the same inclusion and exclusion criteria and study protocol of NIHR TIMES WP3.

Objective sleep data via a contactless sleep radar (Somnofy+) will be continuously assessed and concordance checked against subjective reports. Qualitative analysis of the acceptability by carers of using the device will be carried out.

After the TIMES intervention, participating GPs will be provided with the objective outcome measures of sleep to consider their practicality /usefulness for supporting the clinical decision-making targeting sleep improvement in PLWD in the future.

If the proposed method proves feasible to measure objective sleep quality in PLWD and useful for clinical decision-making targeting sleep quality improvement in PLWD, a device trial (RCT) will be developed to investigate the enhanced efficacy of the TIMES clinical decision tool when informed by objective sleep assessment data.

This approach will also provide an objective and potentially more sensitive assessment of the effectiveness of TIMES decision tool on sleep quality improvement in PLWD.