Feasibility study to investigate the effect of sleep interventions on sleep quality and daytime function in people living with prodromal or mild to moderate Alzheimer’s disease
Adults (aged 50 - 90 years) with a confirmed diagnosis of prodromal or mild-to-moderate Alzheimer’s disease
Participants are allocated to intervention types based on interest and eligibility (non-random). Participants may be eligible only for one intervention or for both. For participants undergoing both interventions, the order of interventions is randomised in a 1:1 ratio. Each intervention has three conditions, and the order of the conditions within an intervention is determined using stratified block randomisation. To ensure an even distribution and control for order effects, participants are assigned to predefined sequences of the three conditions within an intervention (e.g., ABC, BCA, CAB). Randomisation is performed in blocks of 3 for each intervention. The randomisation sequences were produced using a computer-generated algorithm in R. Positional therapy: 1. 7 days with no device - baseline 2. 7 days with active intervention – positional therapy device 3. 7 days with sham intervention – positional therapy device non-functioning The order of the active and sham intervention will be randomised. The device to be used will be the Nightshift Sleep Positioner device or BUZZPod and these devices will be worn around the chest each night. Active condition: if the wearer moves onto their back, the device will gently vibrate and gradually increase in intensity until the user changes position. Sham condition: no vibrations when user changes position Nap: 1. Morning nap condition: 7 days of a 30-minute nap scheduled between 10:00 AM and 11:00 AM 2. Afternoon nap condition: 7 days of a 30-minute nap scheduled between 3:00 PM and 4:00 PM 3. No napping condition: 7 days where participants avoid napping during the day Participants will be provided with a white noise machine that they may choose to use during their naps. The order of the interventions will be randomised.
People living with Alzheimer’s disease (PLWAD): 1. Male or female aged 50 – 90 years at baseline 2. Have a confirmed diagnosis of prodromal or mild to moderate Alzheimer’s disease confirmed by the Surrey and Borders Partnership (SABP) team 3. Have a Standardized Mini-Mental State Examination (SMMSE) score of 15 - 25 4. Be willing and able to give written and oral informed consent 5. Be willing and able to complete all required study procedures, on the judgement of the investigator team 6. Be willing to reside in one place (i.e., home) for the intervention period 7. Have sufficient functional English to allow completion of the assessment instruments 8. If taking hypnotics, or any other medication to support sleep, e.g., psychotropic medications, must have been on a stable dose for 3 months prior to being recruited with no anticipation of changing the dose during the study 9. Be registered with a GP 10. Living in the community 11. If on anti-dementia medication (cholinesterase inhibitors and/or memantine), then must have been on a stable dose for three months prior to being recruited with no anticipation of changing the dose during the study Nap study only: 1. Must be a habitual daytime napper – taking a daytime nap on the majority of days Positional therapy intervention only: 1. Have a score of intermediate or high risk of sleep apnoea on the STOP-BANG questionnaire Study partner (optional – if the PLWAD has a study partner living with them, they will be invited to participate): 1. Male and female aged 18 years or over 2. Single nominated study partner (relative/friend/caregiver) who has known and lives with the PLWAD for at least 6 months and is able to support them with their study participation 3. Have no cognitive impairment, confirmed with an sMMSE score of 27 or greater
PLWAD: 1. A medical condition which is disabling, i.e., prevents the participant from being active, going outside, or being able to perform daily activities, in the judgement of the investigator team 2. A medical condition which requires frequent visits from a healthcare professional or visits to a GP surgery or hospital, which may interfere with study conduct in the judgement of the investigator team 3. A medical condition which is unstable and may interfere with study conduct in the judgement of the investigator team 4. A medical condition which requires a treatment which is not compatible with the protocol, e.g., continuous positive airway pressure (CPAP) treatment, in the judgement of the investigator team 5. A medical condition which would make it unsafe to participate in the research, e.g., poorly controlled diabetes, epilepsy, heart disease, or any other condition in the judgement of the investigator team 6. Alcohol intake exceeds 14 units per week 7. Receipt of any investigational drug within 90 days prior to consenting 8. People with unstable mental states, including severe depression, severe psychosis, agitation, and anxiety, whose medication was changed over the last 4 weeks prior to screening as assessed by the principal investigator (PI) 9. People with severe sensory impairment (severe hearing or visual loss that is not correctable with hearing aids or glasses) 10. Currently have active suicidal ideas as assessed by the SABP team at screening 11. People who require regular elective hospital admission for their physical health monitoring 12. People who are receiving treatment for terminal illness