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

March 20, 2024 updated by: Northumbria University

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Slow sleep spindle density
Time Frame: During night immediately after tDCS administration
PSG-measured slow (11.99Hz) sleep spindle density
During night immediately after tDCS administration
Slow sleep spindle amplitude
Time Frame: During night immediately after tDCS administration
PSG-measured slow (11.99Hz) sleep spindle amplitude.
During night immediately after tDCS administration
Fast sleep spindle density
Time Frame: During night immediately after tDCS administration
PSG-measured fast (13-14.99Hz) sleep spindle density.
During night immediately after tDCS administration
Fast sleep spindle amplitude
Time Frame: During night immediately after tDCS administration
PSG-measured fast (13-14.99Hz) sleep spindle amplitude.
During night immediately after tDCS administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northumbria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of East Anglia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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