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Clinical Trials/NCT05375552
NCT05375552SuspendedNot Applicable

The Effect of Transcranial Direct Current Stimulation Upon Sleep Spindles in Healthy Older Adults: a Pilot Randomised Controlled Study

Northumbria University2 sites in 1 country15 target enrollmentStarted: June 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Enrollment
15
Locations
2
Primary Endpoint
Slow sleep spindle density

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy sleeper older adults aged ≥ 60 years

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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