Is it possible to assess novel technology for monitoring sleep and daily rhythms in people living with mild dementia?
| ISRCTN | ISRCTN10509121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10509121 |
| IRAS number | 311763 |
| Secondary identifying numbers | SRCDRI006 / NIHR-403, IRAS 311763, CPMS 54163 |
- Submission date
- 12/01/2023
- Registration date
- 08/02/2023
- Last edited
- 23/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Dementia is a syndrome (a group of related symptoms) associated with an ongoing decline of brain functioning. Alzheimer's disease is a type of dementia.
Sleep problems in dementia profoundly affect the wellbeing of those living with mild cognitive impairment or dementia and their caregivers. Disturbed sleep may be an indicator of disease progression or may in fact drive the development of the disease. As such, sleep is among the most promising targets for treatment in several different types of dementia. In order to effectively carry out long-term sleep monitoring at home, it requires technology that is acceptable, accurately measures sleep in those living with dementia, and is cost-effective.
In this study, we will evaluate the feasibility of assessing sleep in people living with mild cognitive impairment or mild Alzheimer's disease. In addition, we will assess these parameters in the study partners of the people living with dementia (PLWD) as there is limited data available on the impact of caring for PLWD on the sleep and circadian rhythms of the partner/family member/friend/support. We will also assess age-matched controls without dementia.
Who can participate?
Persons aged 50 - 85 years old with or without mild cognitive impairment or Alzheimer’s disease
What does the study involve?
Roughly 50 participants will be recruited to the study in total. The research will last approximately 2 years, with individual participant involvement being around 15 days.
We will assess the acceptability and performance of a variety of sleep/circadian monitoring devices and the information obtained will also provide us with preliminary information about the relationship between disease status/clinical symptoms and sleep/circadian rhythms. We will be collecting blood and urine samples for analysis of indicators of brain rhythms and function, including expression of genes known to vary with time of day and dementia risk.
What are the possible benefits and risks of participating?
Participation in this study will not benefit you directly, but the information we get from this study may help improve the treatment of people living with dementia. We may also detect something relevant to your health e.g., sleep apnoea.
Before participating you should consider if this will affect any insurance you have and seek advice if necessary.
Some insurance companies treat participation in studies of this nature as a material fact that should be mentioned when making any proposal for health-related insurance. Accordingly, your participation in this study should be disclosed to any insurer if you are in the process of seeking or renewing any such insurance, and you should check that participation does not affect any existing policies you may hold. Further information and advice can be obtained from the study doctor.
Where is the study run from?
University of Surrey (UK)
When is the study starting and how long is it expected to run for?
June 2022 to April 2024
Who is funding the study?
UK Dementia Research Institute
Who is the main contact?
Prof Derk-Jan Dijk, d.j.dijk@surrey.ac.uk
Contact information
Scientific
Surrey Sleep Research Centre
Egerton Road
Guildford
GU2 7XP
United Kingdom
 ORCID ID |
0000-0001-5314-1008 |
|---|---|
| Phone | +44 1483689797 |
| d.j.dijk@surrey.ac.uk |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home, Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Feasibility study to monitor sleep and circadian rhythms in people living with (mild) cognitive impairment or (mild) Alzheimer’s disease and healthy volunteers |
| Study objectives | The purpose of the study is to evaluate the feasibility of assessing sleep and circadian rhythms both at home and in the laboratory in people living with mild cognitive impairment (MCI) and mild Alzheimer’s Disease (AD) (people living with dementia, PLWD). In addition, we will assess these parameters in the study partners of the PLWD as there is limited data available on the impact of caring for PLWD on the sleep and circadian rhythms on the partner/family member/friend/support. We will also assess healthy volunteers without dementia aged 50 – 85 years (we already have comparative data in heterogenous older participants (65 – 80 years) collected in a similar protocol). We will assess the acceptability and performance of a variety of sleep/circadian monitoring devices and the information obtained will also provide us with preliminary information about the relationship between disease status/clinical symptoms and sleep/circadian rhythms. The validation of novel sleep/circadian devices in PLWD will allow us to identify devices for long-term monitoring of sleep/circadian rhythms for tracking disease progression and allow for delivery/monitoring of targeted interventions. Assessment of blood-based biomarkers of sleep/circadian/dementia will provide us with further methodology for assessing disease progression. |
| Ethics approval(s) | Approved 02/11/2022, London - City and East REC (Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT, UK; +44 207 1048134; cityandeast.rec@hra.nhs.uk), ref: 22/LO/0694 |
| Health condition(s) or problem(s) studied | Mild cognitive impairment or mild Alzheimer’s disease |
| Intervention | In this study, we will evaluate the feasibility of assessing sleep in people living with mild cognitive impairment or mild Alzheimer's disease. In addition, we will assess these parameters in the study partners of the people living with dementia (PLWD) as there is limited data available on the impact of caring for PLWD on the sleep and circadian rhythms of the partner/family member/friend/support. We will also assess age-matched controls without dementia. Roughly 50 participants will be recruited to the study in total. The research will last approximately 2 years, with individual participant involvement being around 15 days. We will assess the acceptability and performance of a variety of sleep/circadian monitoring devices and the information obtained will also provide us with preliminary information about the relationship between disease status/clinical symptoms and sleep/circadian rhythms. We will be collecting blood and urine samples for analysis of indicators of brain rhythms and function, including expression of genes known to vary with time of day and dementia risk. This research may lead to the improvement of existing and the development of new technologies and approaches to monitor sleep and brain function. This involvement will help us gain initial data and a further understanding that will help guide future studies in dementia. Participants will undergo a screening visit to determine if they are eligible to take part in the study. This will include completion of questionnaires and clinical assessments. Eligible participants will be provided with a range of devices and tools to use for 14 days at home to monitor their sleep and circadian rhythms. At the end of this period they will be invited to attend the laboratory for an overnight residential session which will include sleep monitoring and collection of blood samples for measurement of biomarkers. |
| Intervention type | Other |
| Primary outcome measure | 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 2. Number of participants completing the protocol: Completion rate recorded as the number of eligible participant who complete Session 3 by 18 months 3. Completeness of data: Completeness will be assessed as the number of day/night recordings per device per participants expressed as a percentage 4. Acceptability of devices: Acceptability assessed by scores given for comfort and ease of use by each participant per device. |
| Secondary outcome measures | 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: 1. Sensitivity (ability to correctly classify sleep epochs) 2. Specificity (ability to correctly classify wake epochs) 3. Accuracy (proportion of all epochs correctly detected) |
| Overall study start date | 30/06/2022 |
| Completion date | 23/04/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 39 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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. |
| Date of first enrolment | 25/01/2023 |
| Date of final enrolment | 09/04/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Randalls Road
Leatherhead
KT22 7AD
United Kingdom
Guildford
GU2 7XP
United Kingdom
Sponsor information
University/education
Stag Hill
Guildford
GU2 7XH
England
United Kingdom
| Phone | +44 1483689797 |
|---|---|
| rigo@surrey.ac.uk | |
| Website | http://www.surrey.ac.uk/ |
"ROR" |
https://ror.org/00ks66431 |
Funders
Funder type
Research organisation
Private sector organisation / Research institutes and centers
- Alternative name(s)
- UK DRI Ltd, UK DRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 29/02/2024 | 23/08/2024 | Yes | No |
Editorial Notes
23/08/2024: The following changes were made to the study record:
1. Publication reference and total final enrolment added.
2. The recruitment end date was changed from 01/08/2024 to 09/04/2024.
3. The overall study end date was changed from 30/01/2025 to 23/04/2024.
01/03/2023: Internal review.
06/02/2023: Trial's existence confirmed by London - City and East REC.
