NCT05375552

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

May 5, 2022

Last Update Submit

March 20, 2024

Conditions

SleepAgingHealthy Aging

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Active transcranial direct current stimulation

ACTIVE COMPARATOR

Active transcranial direct current stimulation

Device: Transcranial direct current stimulation

Placebo transcranial direct current stimulation

PLACEBO COMPARATOR

Placebo transcranial direct current stimulation

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

Participants will experience two repeated 20 minute sessions of tDCS (1.2 mA), with a 10-minute break.

Active transcranial direct current stimulationPlacebo transcranial direct current stimulation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy sleeper older adults aged ≥ 60 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 16, 2022

Study Start

June 1, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

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.

Locations

GB(1)