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

NCT06686563 | Enrolling By Invitation

• 1 other identifier: WAVE_56/CE-IPSN/2023
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Cognitive screening

  Montreal Cognitive Assessment (MoCA)

  From enrollment to the end of intervention

• Performance of the dual motor-cognitive task

  Timed Up and Go (TUG)

  From enrollment to the end of intervention

• Blood biomarkers for chronic inflammatory conditions

  From enrollment to the end of intervention

Secondary Outcomes (1)

• Depressive symptoms

  From enrollment to the end of intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the IG will 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. The participants will be assessed (regarding the outcomes previously described) at the baseline and reassessed after 3 months.

Other: Intervention Group: Gamma stimulation

Control Group

ACTIVE COMPARATOR

Participants in the CG 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. The participants will be assessed (regarding the outcomes previously described) at the baseline and reassessed after 3 months.

Other: Control Group: Theta stimulation

Interventions

Intervention Group: Gamma stimulation OTHER

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.

Intervention Group

Control Group: Theta stimulation OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Know how to read and write

Sponsors & Collaborators

• Maria Paço: lead
• Universidade do Sul de Santa Catarina: collaborator

Study Sites (1)

Cooperativa Ensino Superior Politécnico e Universitário

Gandra, Paredes, 4585-116, Portugal

Location

Related Publications (12)

• Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.

  PMID: 21514249 BACKGROUND

• Singh-Manoux A, Kivimaki M, Glymour MM, Elbaz A, Berr C, Ebmeier KP, Ferrie JE, Dugravot A. Timing of onset of cognitive decline: results from Whitehall II prospective cohort study. BMJ. 2012 Jan 5;344:d7622. doi: 10.1136/bmj.d7622.

  PMID: 22223828 BACKGROUND

• Ramos LR, Simoes EJ, Albert MS. Dependence in activities of daily living and cognitive impairment strongly predicted mortality in older urban residents in Brazil: a 2-year follow-up. J Am Geriatr Soc. 2001 Sep;49(9):1168-75. doi: 10.1046/j.1532-5415.2001.49233.x.

  PMID: 11559375 BACKGROUND

• Yesavage JA, O'Hara R, Kraemer H, Noda A, Taylor JL, Ferris S, Gely-Nargeot MC, Rosen A, Friedman L, Sheikh J, Derouesne C. Modeling the prevalence and incidence of Alzheimer's disease and mild cognitive impairment. J Psychiatr Res. 2002 Sep-Oct;36(5):281-6. doi: 10.1016/s0022-3956(02)00020-1.

  PMID: 12127595 BACKGROUND

• Morris JC, Storandt M, Miller JP, McKeel DW, Price JL, Rubin EH, Berg L. Mild cognitive impairment represents early-stage Alzheimer disease. Arch Neurol. 2001 Mar;58(3):397-405. doi: 10.1001/archneur.58.3.397.

  PMID: 11255443 BACKGROUND

• Franceschi C, Garagnani P, Parini P, Giuliani C, Santoro A. Inflammaging: a new immune-metabolic viewpoint for age-related diseases. Nat Rev Endocrinol. 2018 Oct;14(10):576-590. doi: 10.1038/s41574-018-0059-4.

  PMID: 30046148 BACKGROUND

• Krogh J, Benros ME, Jorgensen MB, Vesterager L, Elfving B, Nordentoft M. The association between depressive symptoms, cognitive function, and inflammation in major depression. Brain Behav Immun. 2014 Jan;35:70-6. doi: 10.1016/j.bbi.2013.08.014. Epub 2013 Sep 7.

  PMID: 24016864 BACKGROUND

• Borges SM, Radanovic M, Forlenza OV. Correlation between functional mobility and cognitive performance in older adults with cognitive impairment. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2018 Jan;25(1):23-32. doi: 10.1080/13825585.2016.1258035. Epub 2016 Dec 9.

  PMID: 27934540 BACKGROUND

• Tang HY, Riegel B, McCurry SM, Vitiello MV. Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia? Appl Psychophysiol Biofeedback. 2016 Mar;41(1):39-46. doi: 10.1007/s10484-015-9308-7.

  PMID: 26294268 BACKGROUND

• Tang HY, Vitiello MV, Perlis M, Mao JJ, Riegel B. A pilot study of audio-visual stimulation as a self-care treatment for insomnia in adults with insomnia and chronic pain. Appl Psychophysiol Biofeedback. 2014 Dec;39(3-4):219-25. doi: 10.1007/s10484-014-9263-8.

  PMID: 25257144 BACKGROUND

• Derner M, Chaieb L, Surges R, Staresina BP, Fell J. Modulation of Item and Source Memory by Auditory Beat Stimulation: A Pilot Study With Intracranial EEG. Front Hum Neurosci. 2018 Dec 11;12:500. doi: 10.3389/fnhum.2018.00500. eCollection 2018.

  PMID: 30618681 BACKGROUND

• Chaieb L, Wilpert EC, Hoppe C, Axmacher N, Fell J. The Impact of Monaural Beat Stimulation on Anxiety and Cognition. Front Hum Neurosci. 2017 May 15;11:251. doi: 10.3389/fnhum.2017.00251. eCollection 2017.

  PMID: 28555100 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Anna Quialheiro, PhD

  Cooperativa de Ensino Superior, Politécnico e Universitário

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: November 13, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)