Background While sleep disturbance is common in dementia, leading to negative outcomes, there is growing evidence that sleep disturbance begins early in prodromal dementia and may contribute to cognitive decline. Sleep is therefore an important treatment target throughout the natural history of dementia and there is increasing interest in sleep as a modifiable risk factor. Clinical trials of interventions to improve sleep in people with cognitive impairment are beset by wide heterogeneity in the outcome measures reported. A core outcome set (COS) is urgently required to improve the coherence and comparability of data. Aim To produce a COS for clinical trials of interventions to improve sleep in people with cognitive impairment: the Sleep in Cognitive Impairment Core Outcome Set (SCICOS). Methods The Core Outcome Set-STAndards for Development: the COS-STAD recommendations will be followed. A systematic review (Registration: CRD42024556750) will identify outcome measures used in relevant clinical trials. Qualitative interviews involving people living with cognitive impairment and their caregivers will ascertain the outcome measures important to them. Finally, a modified Delphi process, involving people living with cognitive impairment and their caregivers as well as expert clinicians and researchers, will be conducted to reach consensus regarding the final composition of the SCICOS. Conclusion Interventions to improve sleep in people with cognitive impairment may reduce distress associated with sleep disturbance and, potentially, slow progression of cognitive decline. Creating the SCICOS will facilitate development of more meaningful and coherent data to drive progress in this emerging field.
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