ISRCTN79716324 · RECRUITING
Is it possible to assess sleep interventions aimed at improving sleep quality and daytime function in people with mild dementia?
This small UK study is testing whether two at-home sleep approaches can be carried out by people with early to mild-moderate Alzheimer's: scheduled short daytime naps, and a positional device meant to ease breathing problems during sleep. It tracks sleep and daytime function. Phase is unspecified. It is a feasibility study, asking whether this can be done, not whether it works.
Eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-05-13
Source: ISRCTN registry, record ISRCTN79716324, retrieved 2026-10-27. Registry text licensed CC BY 4.0.