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

Sponsor
Northumbria University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05375552
Collaborator
University of East Anglia (Other)
15
2
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial direct current stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Effect of Transcranial Direct Current Stimulation Upon Sleep Spindles in Healthy Older Adults: a Pilot Randomised Controlled Study
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active transcranial direct current stimulation

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

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.

Outcome Measures

Primary Outcome Measures

  1. Slow sleep spindle density [During night immediately after tDCS administration]

    PSG-measured slow (11.99Hz) sleep spindle density

  2. Slow sleep spindle amplitude [During night immediately after tDCS administration]

    PSG-measured slow (11.99Hz) sleep spindle amplitude.

  3. Fast sleep spindle density [During night immediately after tDCS administration]

    PSG-measured fast (13-14.99Hz) sleep spindle density.

  4. Fast sleep spindle amplitude [During night immediately after tDCS administration]

    PSG-measured fast (13-14.99Hz) sleep spindle amplitude.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northumbria University
  • University of East Anglia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northumbria University
ClinicalTrials.gov Identifier:
NCT05375552
Other Study ID Numbers:
  • NCSR422
First Posted:
May 16, 2022
Last Update Posted:
May 16, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 16, 2022