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WAVE: AudioVisual Stimulation Enhances Cognitive, Mental and Physical Health in Elderly

Audiovisual Stimulation in Elderly (Older Adults?): Effects on Cognition, Depressive Symptoms, and Dual Motor-Cognitive Tasks - a RCT

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06686563
Enrollment
48
Registered
2024-11-13
Start date
2024-11-30
Completion date
2025-03-31
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Cognitive decline, Depressive symptoms, Audiovisual stimulation, Inflammaging, Older adults

Brief summary

The goal of this randomized controlled trial is to 1) carry out a screening of cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults; 2) analyze the influence of AVNS on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults. The main question it aims to answer is: Does AVNS have influence on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults . Participants will be randomly assigned to a control group or to a intervention group, where they will use AVNS to see if influences the above mentioned outcomes, compared to the no intervention (control) group.

Detailed description

Mild Cognitive Impairment (MCI) can be defined as a pre-dementia symptom and, when associated with aging, characterizes individuals with cognitive decline below the level of dementia. This decline, which can begin as early as 45 years of age, leads to impairments in memory, learning, language, orientation, and executive functions, which are more visible from the sixth decade of life onwards, with a risk of reduced autonomy and independence, and is seen by researchers as the first stage of a process of loss. This loss is progressive, lasting several years and resulting in MCI, characterized by objective cognitive loss, which does not yet compromise autonomy but has a conversion rate to dementia of 10% per year. Cognitive decline can be accompanied by increased depressive symptoms and decreased functional capacity and is related to inflammatory conditions, described in the literature as inflammaging. Studies with beat stimulation have shown benefits in different important outcomes of cognitive function and depression. Thus, audiovisual neurostimulation (AVNS) is a possible non-pharmacological treatment that might have a direct influence on the brain wave patterns, altered in MCI and depression, modulating these specific wave frequencies to functional patterns similar to those found in healthy individuals. Having this, it can also influence agility and functional balance and reduce chronic inflammatory conditions.

Interventions

OTHERIntervention Group: Gamma stimulation

Participants in this group be stimulated with gamma frequency (39-42 Hz). The frequency of the intervention will be 5 times a week, with the AVNS being used twice a week for 20 minutes (a minimum of 20 sessions - 8 to 12 weeks) and the other 3 days being spent at home with 20 minutes of audio frequency stimulation.

OTHERControl Group: Theta stimulation

Participants in this group will be stimulated with theta frequency (4-7 Hz). The frequency of the intervention will be 5 times a week, with the AVNS being used twice a week for 20 minutes (a minimum of 20 sessions - 8 to 12 weeks) and the other 3 days being spent at home with 20 minutes of audio frequency stimulation.

Sponsors

Universidade do Sul de Santa Catarina
CollaboratorOTHER_GOV
Maria Paço
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

A double-blind randomized controlled clinical trial will be conducted with 48 elderly volunteers from a daycare center in Famalicão. After an initial cognitive screening (MoCA), assessment of depressive symptoms (GDS-15), agility and functional balance (TUG), and chronic inflammatory conditions (blood analysis), participants will be randomly assigned to a group (IG: intervention group; CG: control group). Participants in the CG will be stimulated with theta frequency (4-7 Hz), while participants in the IG will be stimulated with gamma frequency (39-42 Hz). For both groups, the frequency of the intervention will be 5 times a week, with the AVNS being used twice a week for 20 minutes (a minimum of 20 sessions - 8 to 12 weeks) and the other 3 days being spent at home with 20 minutes of audio frequency stimulation at the appropriate frequency (GC: theta, GI: gamma). After this period, all participants will be re-evaluated.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Know how to read and write

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Cognitive screeningFrom enrollment to the end of interventionMontreal Cognitive Assessment (MoCA)
Performance of the dual motor-cognitive taskFrom enrollment to the end of interventionTimed Up and Go (TUG)
Blood biomarkers for chronic inflammatory conditionsFrom enrollment to the end of intervention

Secondary

MeasureTime frameDescription
Depressive symptomsFrom enrollment to the end of interventionGeriatric Depressive Scale 15 items (GDS-15)

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026