SleepNCT05375552
The Effect of Transcranial Direct Current Stimulation Upon Sleep Spindles in Healthy Older Adults
A study testing Transcranial direct current stimulation in people with Sleep and Aging, run by Northumbria University at 1 site in United Kingdom.
Trial summary
A good quantity, and quality, of sleep is crucial for well-being. Evidence strongly indicates that poor sleep quality and quantity is causally involved in the development of dementia; therefore, techniques which can improve sleep in older adults are very likely to prevent or slow down the disease process in dementia. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Aging, Healthy Aging
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy sleeper older adults aged ≥ 60 years
Who cannot join
- The presence of self-reported neurodegenerative dementia or other neurological disorders
- Self-reported relevant sleep disorders or disturbances
- Relevant skin allergies
- Concurrent major psychiatric illness
- Significant/severe physical illness or comorbidities
- Metallic or electronic implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Transcranial Direct Current Stimulation Upon Sleep Spindles in Healthy Older Adults: a Pilot Randomised Controlled Study
A good quantity, and quality, of sleep is crucial for well-being. Evidence strongly indicates that poor sleep quality and quantity is causally involved in the development of dementia; therefore, techniques which can improve sleep in older adults are very likely to prevent or slow down the disease process in dementia.
This project aims to manipulate a specific aspect of sleep in healthy older adults. This: 1) has the potential to prevent the pre-dementia stage of mild cognitive impairment in healthy older adults, and 2) has a direct clinical application to dementia. The overall aim of this project is to investigate if a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) can enhance specific brain activity patterns during overnight sleep in healthy older adults.
Read more
These brain activity patterns during sleep (called 'sleep spindles') are mechanistically linked to both the physiological restorative and the cognitive function of sleep. Sleep spindles can only be assessed by measuring overnight brain activity during sleep. Sleep spindles are very strongly associated with attention, and memory performance, which are severely affected by dementia. A decrease in sleep spindles is associated with cognitive decline, and predict dementia development. Therefore, enhancing sleep spindle activity in sleep is likely to boost cognition.
Whilst previous research studies have demonstrated that in a sleep laboratory environment, tDCS can manipulate sleep spindles when individuals are in a specific brain state in a nap situation, we are specifically interested in testing tDCS in a home environment. This is because the use of tDCS in a home environment has have a number of advantages over sleep laboratory studies. Specifically, by conducting this study in a home environment, this will maximise the inclusivity of studies involving older adults, and DLB patients, since they will not be required to travel to a sleep laboratory to participate in studies.
The aim of this proof-of-principle study is to investigate if tDCS can manipulate sleep spindles in healthy older adults. It is expected that relative to a placebo stimulation, active stimulation (which exerts an effect upon the brain) will increase sleep spindle activity in healthy older adults.
- Conditions
- Sleep, Aging, Healthy Aging
- Being tested
- Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Participants will experience two repeated 20 minute sessions of tDCS (1.2 mA), with a 10-minute break.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial direct current stimulation | Active comparator | Active transcranial direct current stimulation Receives: Device: Transcranial direct current stimulation |
| Placebo transcranial direct current stimulation | Placebo comparator | Placebo transcranial direct current stimulation Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow sleep spindle density
PSG-measured slow (11.99Hz) sleep spindle density
Measured: During night immediately after tDCS administration
Slow sleep spindle amplitude
PSG-measured slow (11.99Hz) sleep spindle amplitude.
Measured: During night immediately after tDCS administration
Fast sleep spindle density
PSG-measured fast (13-14.99Hz) sleep spindle density.
Measured: During night immediately after tDCS administration
Fast sleep spindle amplitude
PSG-measured fast (13-14.99Hz) sleep spindle amplitude.
Measured: During night immediately after tDCS administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Jun 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: Recruitment has been suspended due to a lack of available staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375552
- Sponsor's protocol ID
- NCSR422
- Status last verified
- Mar 2024
- First submitted
- 5 May 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study will be available from the principal investigator upon reasonable request (after a period of exclusive use (12 months). Our intended policy is that the research team will have exclusive use of the data for a period of 12 months from the end of the project, or until the data is published, if this is required alongside publications. Anonymised data will be provided and data will be made available upon application and the research team would control access in line with Northumbria University guidelines, however, data access will not reasonably be refused. There is no provision for public access to the protocol, statistical code and dataset, although reasonable requests will be accommodated in line with the intended use policy stated above.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation Upon Sleep Spindles in Healthy Older Adults: a Pilot Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05375552
- Acronym / sponsor ID
- NCSR422
- Conditions
- Sleep, Aging, Healthy Aging
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment has been suspended due to a lack of available staff.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A good quantity, and quality, of sleep is crucial for well-being. Evidence strongly indicates that poor sleep quality and quantity is causally involved in the development of dementia; therefore, techniques which can improve sleep in older adults are very likely to prevent or slow down the disease process in dementia.
This project aims to manipulate a specific aspect of sleep in healthy older adults. This: 1) has the potential to prevent the pre-dementia stage of mild cognitive impairment in healthy older adults, and 2) has a direct clinical application to dementia. The overall aim of this project is to investigate if a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) can enhance specific brain activity patterns during overnight sleep in healthy older adults.
These brain activity patterns during sleep (called 'sleep spindles') are mechanistically linked to both the physiological restorative and the cognitive function of sleep. Sleep spindles can only be assessed by measuring overnight brain activity during sleep. Sleep spindles are very strongly associated with attention, and memory performance, which are severely affected by dementia. A decrease in sleep spindles is associated with cognitive decline, and predict dementia development. Therefore, enhancing sleep spindle activity in sleep is likely to boost cognition.
Whilst previous research studies have demonstrated that in a sleep laboratory environment, tDCS can manipulate sleep spindles when individuals are in a specific brain state in a nap situation, we are specifically interested in testing tDCS in a home environment. This is because the use of tDCS in a home environment has have a number of advantages over sleep laboratory studies. Specifically, by conducting this study in a home environment, this will maximise the inclusivity of studies involving older adults, and DLB patients, since they will not be required to travel to a sleep laboratory to participate in studies.
The aim of this proof-of-principle study is to investigate if tDCS can manipulate sleep spindles in healthy older adults. It is expected that relative to a placebo stimulation, active stimulation (which exerts an effect upon the brain) will increase sleep spindle activity in healthy older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcranial direct current stimulation | Active comparator | Device: Transcranial direct current stimulationActive transcranial direct current stimulation |
| Placebo transcranial direct current stimulation | Placebo comparator | Device: Transcranial direct current stimulationPlacebo transcranial direct current stimulation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy sleeper older adults aged ≥ 60 years
Key exclusion criteria (6 listed)
- The presence of self-reported neurodegenerative dementia or other neurological disorders
- Self-reported relevant sleep disorders or disturbances
- Relevant skin allergies
- Concurrent major psychiatric illness
- Significant/severe physical illness or comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationParticipants will experience two repeated 20 minute sessions of tDCS (1.2 mA), with a 10-minute break. | Device | Active transcranial direct current stimulation, Placebo transcranial direct current stimulation |
Primary outcome
Slow sleep spindle density
Time frame: During night immediately after tDCS administration
PSG-measured slow (11.99Hz) sleep spindle density
Slow sleep spindle amplitude
Time frame: During night immediately after tDCS administration
PSG-measured slow (11.99Hz) sleep spindle amplitude.
Fast sleep spindle density
Time frame: During night immediately after tDCS administration
PSG-measured fast (13-14.99Hz) sleep spindle density.
Fast sleep spindle amplitude
Time frame: During night immediately after tDCS administration
PSG-measured fast (13-14.99Hz) sleep spindle amplitude.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study will be available from the principal investigator upon reasonable request (after a period of exclusive use (12 months). Our intended policy is that the research team will have exclusive use of the data for a period of 12 months from the end of the project, or until the data is published, if this is required alongside publications. Anonymised data will be provided and data will be made available upon application and the research team would control access in line with Northumbria University guidelines, however, data access will not reasonably be refused. There is no provision for public access to the protocol, statistical code and dataset, although reasonable requests will be accommodated in line with the intended use policy stated above.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Sleep and Aging, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow sleep spindle density (time frame: During night immediately after tDCS administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.