The Effect of Transcranial Direct Current Stimulation Upon Sleep Spindles in Healthy Older Adults

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.

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 Overview

• Status: Suspended
• Conditions: Sleep; Aging; Healthy Aging
• Intervention / Treatment: Device: Transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle Upon Tyne, United Kingdom
    • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active transcranial direct current stimulation	Device: Transcranial direct current stimulation; Participants will experience two repeated 20 minute sessions of tDCS (1.2 mA), with a 10-minute break.
Placebo Comparator: Placebo transcranial direct current stimulation	Device: Transcranial direct current stimulation; Participants will experience two repeated 20 minute sessions of tDCS (1.2 mA), with a 10-minute break.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slow sleep spindle density	PSG-measured slow (11.99Hz) sleep spindle density	During night immediately after tDCS administration
Slow sleep spindle amplitude	PSG-measured slow (11.99Hz) sleep spindle amplitude.	During night immediately after tDCS administration
Fast sleep spindle density	PSG-measured fast (13-14.99Hz) sleep spindle density.	During night immediately after tDCS administration
Fast sleep spindle amplitude	PSG-measured fast (13-14.99Hz) sleep spindle amplitude.	During night immediately after tDCS administration

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: University of East Anglia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NCSR422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No