INTRODUCTION
Sleep disturbances are common in older people with cognitive impairment, potentially contributing to negative outcomes. A core outcome set (COS) is required to reduce heterogeneity in clinical trials and promote the development of high-quality evidence to support clinical management.
METHODS
A multi-stage mixed methods study was conducted in accordance with The Core Outcome Set Standards for Development.
RESULTS
A systematic review identified 287 sleep outcomes from previous clinical trials. Qualitative interviews ensured the COS was informed by what matters most to people with cognitive impairment and their caregivers. A modified Delphi process identified nine outcomes for the COS: total sleep time, sleep onset latency, wakefulness after sleep onset, number of night-time awakenings, sleep efficiency, and measures of sleep quality, daytime sleepiness, cognition, and mood.
DISCUSSION
This COS will support researchers to produce more reliable and coherent trial data to guide the management of sleep disturbances in people with neurodegenerative cognitive impairment.
Highlights
- Evidence is lacking regarding the treatment of sleep disturbances in people with cognitive impairment.
- Heterogeneity of reported outcomes in clinical trials limits data synthesis.
- A qualitative analysis established what matters most to people with cognitive impairment and their caregivers when determining treatment effectiveness.
- A Delphi panel of experts agreed upon a core outcome set.
- This core outcome set will improve the reliability and comparability of data from future trials.
Patrick Crowley, Alasdair L. Henry, Evelyn Flanagan, Inga Antonsdottir, Alison Bentley, Jonathan Blackman, Donald L. Bliwise, Omonigho M. Bubu, Daniel J. Buysse, Einstein F. Camargos, Erin Cassidy-Eagle, Kimberly Cote, Elizabeth Coulthard, Angela L. D'Rozario, Colin A. Espie, Ryan S. Falck, Victoria G. Gabb, Allison G. Harvey, Nant Thin Thin Hmwe, Camilla M. Hoyos, Lucy Jobbins, Seán Kennelly, Brianne A. Kent, Sascha Köpke, Andrew Krystal, Iracema Leroi, Claudio Liguori, Yen Ying Lim, Rebecca Lorenz, Brendan P. Lucey, Bryce Mander, Margaret Moline, Sharon L. Naismith, Adesola Ogunniyi, Penny Rapaport, Charles F. Reynolds III, Kathy Richards, Catherine F. Siengsukon, Shireen Sindi, Clifford M. Singer, Anna Wirz-Justice, Kristine Yaffe, Rónán O'Caoimh
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.