Is it possible to assess novel technology for monitoring sleep and daily rhythms in people living with mild dementia?
- Conditions
- Mild cognitive impairment or mild Alzheimer’s diseaseMental and Behavioural Disorders
- Registration Number
- ISRCTN10509121
- Lead Sponsor
- niversity of Surrey
- Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38534798/ (added 23/08/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 39
1. All participants
1.1. Be willing and able to give written and oral informed consent
1.2. Be willing and able to complete all required study procedures, on the judgement of the investigator team
1.3. Be willing to reside in one place (i.e. home) for the 14 day at-home monitoring period
1.4. Have sufficient functional English to allow completion of the assessment instruments
1.5. If taking hypnotics, must have been on a stable dose for 3 months prior to being recruited with no anticipation of changing the dose during the study
1.6. Be registered with a GP
2. Participants living with mild cognitive impairment or Alzheimer’s disease only
2.1. Male or female aged 50 – 85 years at baseline
2.2. Have a confirmed diagnosis of prodromal or mild Alzheimer’s disease confirmed by the SABP team
2.3. Have an sMMSE score of 23 or greater
2.4. Living in the community and have another individual who will support them in their participation by acting as their study partner
2.5. 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
3. Healthy volunteers (will only be recruited if required to age match PLWD aged 50 – 64 years)
3.1. Men and women aged 50 – 85 years at baseline
3.2. Have no cognitive impairment, confirmed with an sMMSE score of 27 or greater
3.3. Any co-morbidities must have been stable for at least the past three months prior to screening, with no change to their current medications and no hospitalisation due to this specific co-morbidity
4. Study Partner
4.1. Men and women aged 18 or over
4.2. Single nominated study partner (relative/friend/caregiver) who has known the person with dementia for at least 6 months and is able to support the person with MCI or AD with their study participation
4.3. Have no cognitive impairment, confirmed with an sMMSE score of 27 or greater
1. All participants
1.1. A medical condition which is disabling, i.e., prevents the participant to be active, go outside, or being able to perform daily activities
1.2. 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
1.3. A medical condition which is unstable and may interfere with study conduct in the judgement of the investigator team
1.4. A medical condition which requires a treatment which is not compatible with the protocol, e.g., CPAP treatment, in the judgement of the investigator team
1.5. 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
1.6. Current smoker. Ex-smokers are eligible provided that they have stopped smoking and not used any cigarettes, nicotine substitutes or vaping for a minimum of 6 months before screening
1.7. Alcohol intake exceeds 14 units per week
1.8. Receipt of any investigational drug within 90 days prior to consenting
2. Participants living with mild cognitive impairment or Alzheimer’s disease
2.1. People with unstable mental state including severe depression, severe psychosis, agitation, and anxiety whom their medication was changed over the last 4 weeks prior to screening as assessed by the PI
2.2. People with severe sensory impairment (severe hearing or visual loss that is not correctable with hearing aids or glasses)
2.3. Currently have active suicidal ideas as assessed by the SABP team at screening
2.4. People who require regular elective hospital admission for their physical health monitoring
2.5. People who are receiving treatment for terminal illness
3. Healthy volunteers (will only be recruited if required to age match PLWD aged 50 – 64 years)
3.1. Participant has travelled across more than one different time zone within two weeks prior to the first screening visit, or plans to travel across more than one time zone during the study.
3.2. Participant has been a night-shift worker (works between 22:00 and 06:30) in the six months prior to screening visits, or plans to be a night-shift worker during the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Successful recruitment of people living with dementia (PLWD): Recruitment rate recorded as the number of eligible participant who consent to participate in the study by 18 months<br>2. Number of participants completing the protocol: Completion rate recorded as the number of eligible participant who complete Session 3 by 18 months<br>3. Completeness of data: Completeness will be assessed as the number of day/night recordings per device per participants expressed as a percentage <br>4. Acceptability of devices: Acceptability assessed by scores given for comfort and ease of use by each participant per device.
- Secondary Outcome Measures
Name Time Method Performance of devices compared to gold-standard measures of sleep and circadian rhythms at home and in the laboratory. For each device that we are using (AX3, Withings Scanwatch, Dreem headband, Somnomedics Home Sleep Test, Withings Sleep Aanalyser, Somnofy) we will compare the 30 second epochs for the 10 hour recording against PSG to determine:<br>1. Sensitivity (ability to correctly classify sleep epochs)<br>2. Specificity (ability to correctly classify wake epochs)<br>3. Accuracy (proportion of all epochs correctly detected)