NCT07051460

Brief Summary

The goal of this observational study is to investigate how oral proprioceptive stimuli affect visual perception and auditory-visual integration in healthy young adults. The main questions it aims to answer are:

  • Can Oral Proprioceptive Stimuli (OPS) induce Visual pseudo-Scotomas (VS) in the absence of other stimuli?
  • Can Oral Proprioceptive Stimuli (OPS) modulate or eliminate Visual pseudo-Scotomas (VS) induced by auditory stimuli? Researchers evaluated 38 healthy adults (aged 20-29) using the Vertical Maddox Test to detect functional visual alterations under different conditions. The study included four phases:
  • Baseline assessment with no stimuli.
  • Assessment with auditory stimuli alone.
  • Assessment with simultaneous auditory and Oral Proprioceptive Stimuli (OPS), including tongue/lip positions (Combined Oral Stimuli) and dental pressure/traction stimuli (Dental Stimuli).
  • Assessment with Oral Proprioceptive Stimuli (OPS) alone. Visual pseudo-scotomas were recorded based on participant responses. The study was approved by the local ethics committee and all participants gave informed consent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 12, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

ProprioceptionMultisensory IntegrationTrigeminal NerveVisual PerceptionPeriodontal MechanoreceptorsStomatognathic System

Outcome Measures

Primary Outcomes (1)

  • Presence of Visual Pseudo-Scotomas (VS) under Auditory and/or Oral Proprioceptive Stimulation

    Participants were assessed for the occurrence of functional visual disturbances (pseudo-scotomas, or VS) during each phase of the protocol using the Vertical Maddox Test. Presence or absence of VS was recorded under three experimental conditions: auditory stimulation alone, combined auditory and oral proprioceptive stimulation, and oral proprioceptive stimulation alone.

    During 4-phase experimental protocol (single visit, approx. 45 minutes)

Secondary Outcomes (2)

  • Elimination of Sound-Induced Visual Pseudo-Scotomas by Oral Proprioceptive Stimuli

    Day 1, during phase 3 (auditory + OPS) of the experimental protocol

  • Presence of Visual Pseudo-Scotomas with Oral Proprioceptive Stimulation Alone

    Day 1, during phase 4 (OPS alone) of the experimental protocol

Study Arms (1)

Healthy adults

Healthy young adult participants (ages 20-29) underwent a 4-phase experimental protocol involving auditory and oral proprioceptive stimuli under controlled conditions, using the Vertical Maddox Test to assess transient visual changes.

Other: Baseline Condition (No Stimuli)Other: Auditory Stimulation onlyOther: Auditory and Oral Proprioceptive Stimulation (OPS)Other: Oral Proprioceptive Stimulation Only (OPS)

Interventions

Participants underwent baseline evaluation using the Vertical Maddox Test with no auditory or oral proprioceptive stimulation. This phase was used to confirm the absence of spontaneous visual pseudo-scotomas and served as an internal control condition for each participant.

Also known as: Phase 1
Healthy adults

Participants received bilateral auditory stimulation consisting of 500 Hz tones (500 ms duration, 50 dB) delivered through wireless headphones, without any accompanying oral stimuli. This condition was used to assess the isolated effect of sound on visual perception using the Vertical Maddox Test.

Also known as: Phase 2
Healthy adults

Participants received simultaneous auditory and oral proprioceptive stimuli while undergoing the Vertical Maddox Test. - Auditory: 500 Hz tones (500 ms, 50 dB) via headphones. - Oral Proprioceptive Stimuli (OPS): included Combined Oral Stimuli (e.g., tongue and lip self-administered positions) and Dental Stimuli (mechanical pressure or traction on central incisors using a calibrated probe). This condition aimed to assess whether OPS could modulate or eliminate sound-induced visual pseudo-scotomas.

Also known as: Phase 3
Healthy adults

Participants received oral proprioceptive stimuli alone, without auditory input, during the Vertical Maddox Test. - Combined Oral Stimuli (COS): self-administered tongue/lip positions. - Dental Stimuli (DS): applied by the operator to central incisors. This condition was used to evaluate the independent effect of OPS on visual perception.

Healthy adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants of the study were healthy young adults recruited among the students of the Faculty of Medicine and Health Sciences of the University of Barcelona, who did not present any of the exclusion criteria listed above.

You may not qualify if:

  • General criteria:
  • Treatment with psychotropic drugs
  • Hearing loss in one or both ears
  • Visual criteria:
  • Visual acuity worse than 20/20 in one or both eyes
  • Stereopsis (three-dimensional vision) less than 120 arc sec
  • Vertical phoria greater than 0.75 Δ
  • Strabismus operated on or not
  • Ongoing optometric rehabilitation
  • History of amblyopia
  • Dental criteria:
  • Missing one or more incisors
  • Presence of conservative, prosthetic or orthodontic treatment on one or more incisors (fillings, root canal treatments, veneers, crowns, brackets, Invisalign type attachments...).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Odontológico Universitat de Barcelona

Barcelona, Spain

Location

Related Publications (2)

  • Quercia P, Pozzo T, Marino A, Guillemant AL, Cappe C, Gueugneau N. Alteration in binocular fusion modifies audiovisual integration in children. Clin Ophthalmol. 2019 Jul 4;13:1137-1145. doi: 10.2147/OPTH.S201747. eCollection 2019.

    PMID: 31308621BACKGROUND
  • Quercia P, Pozzo T, Marino A, Guillemant AL, Cappe C, Gueugneau N. Children with Dyslexia Have Altered Cross-Modal Processing Linked to Binocular Fusion. A Pilot Study. Clin Ophthalmol. 2020 Feb 13;14:437-448. doi: 10.2147/OPTH.S226690. eCollection 2020.

    PMID: 32103890BACKGROUND

MeSH Terms

Interventions

Clinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as Topic

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor Department of Odontostomatology

Study Record Dates

First Submitted

June 12, 2025

First Posted

July 4, 2025

Study Start

December 16, 2022

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

July 4, 2025

Record last verified: 2025-06

Locations