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Is it possible to assess sleep interventions aimed at improving sleep quality and daytime function in people with mild dementia?

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79716324
Enrollment
50
Registered
2026-05-13
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults (aged 50 - 90 years) with a confirmed diagnosis of prodromal or mild-to-moderate Alzheimer’s disease Nervous System Diseases

Interventions

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 in

Sponsors

University of Surrey
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion 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

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

Countries

England, United Kingdom

Contacts

Public ContactJoshua Cudworth
joshua.cudworth@sabp.nhs.uk+44 (0)300 5555 222

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 30, 2026