Background:
While sleep disturbance is common in advanced 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 (Blackman, 2022 - https://www.comet-initiative.org/Studies/Details/2441). 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 patients, caregivers, 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 disturbances 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.
Principal Investigator: Dr. Patrick Crowley, Mercy University Hospital, Cork, Ireland, and University College Cork, Cork, Ireland.
Project Supervisor: Dr. Rónán O'Caoimh, Mercy University Hospital, Cork, Ireland.
Dr. Evelyn Flanagan, Health Research Board-Clinical Research Facility, University College Cork, Cork, Ireland.
Disease Category: Neurology
Disease Name: Dementia
Age Range: 0 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Systematic review
The Core Outcome Set-STAndards for Development: the COS-STAD recommendations will be followed. A systematic review (Registration: CRD42024556750) will identify outcome measures previously used in controlled clinical trials of interventions to improve sleep in people with mild cognitive impairment or dementia. 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 patients, caregivers, clinicians, and researchers will be conducted to reach consensus regarding the final composition of the SCICOS.