ProprioceptionNCT07051460
Study of the Effect of Proprioceptive Stimuli in the Stomatognathic Area on Visual Perception, With and Without Sound
An observational study of Proprioception and Visual Perception, run by Sophie Román Richon at 1 site in Spain.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proprioception, Visual Perception, Multisensory
- What is being tested?
- Baseline Condition (No Stimuli), Auditory Stimulation only and Auditory and Oral Proprioceptive Stimulation (OPS)
- Type of treatment
- Pill or oral medicine
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 16 Dec 2022to 3 Mar 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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...).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MULTISENSORIALIDAD Y BOCA Estudio Del Efecto de estímulos Propioceptivos en el área estomatognática Sobre la percepción Visual, Con y Sin Sonido
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?
Read more
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.
Read the detailed description
Proprioception plays a well-established role in postural control and motor coordination, but increasing evidence supports its involvement in higher-level sensory processing, including spatial localization and multisensory integration. Given the anatomical overlap of trigeminal afferents innervating both oculomotor and orofacial structures, this study focused on the potential interplay between the stomatognathic and visual systems.
This study is an observational investigation with an experimental within-subject design with repeated measures in healthy volunteers.
The aim is to investigate the influence of oral proprioceptive stimuli on visual perception and audiovisual integration in healthy young adults, and explore whether non-invasive oral stimuli could modulate the occurrence of transient visual distortions-specifically Visual pseudo-Scotomas (VS)-when binocular vision is altered, and whether these stimuli could counteract the effects induced by auditory input.
Participants have been screened to ensure normal hearing, vision, and dental status, and underwent testing using the Vertical Maddox Test, which induces a dissociation in binocular vision that relies heavily on proprioceptive cues.
The experimental protocol was composed of four phases:
- Baseline evaluation with no stimuli.
- Application of auditory stimuli (500 Hz tones delivered through headphones) to assess their influence on visual perception.
- Application of simultaneous auditory and Oral Proprioceptive Stimuli (OPS), including both Combined Oral Stimuli (COS, such as specific tongue and lip positions) and Dental Stimuli (DS, consisting of gentle pressure/traction on central incisors using a calibrated probe).
- Application of Oral Proprioceptive Stimuli (OPS) alone, without sound.
Participants were asked to report the occurrence and location of any Visual pseudo-Scotomas (VS) observed during each phase. These were defined as functional visual field losses detected via the Vertical Maddox Test, with no underlying ocular pathology.
This protocol was developed based on prior work investigating ocular and oral proprioception and its role in multisensory integration. No pharmacological agents, devices, or therapeutic interventions were used. The study is observational in nature, and no biospecimens were collected or retained.
- Conditions
- Proprioception, Visual Perception, Multisensory, Stomatognathic System
- Being tested
- Baseline Condition (No Stimuli), Auditory Stimulation only, Auditory and Oral Proprioceptive Stimulation (OPS), Oral Proprioceptive Stimulation Only (OPS)
- Keywords
- Proprioception, Multisensory Integration, Trigeminal Nerve, Visual Perception, Periodontal Mechanoreceptors, Stomatognathic System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Condition (No Stimuli)Other
Also called Phase 1
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.
Auditory Stimulation onlyOther
Also called Phase 2
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.
Auditory and Oral Proprioceptive Stimulation (OPS)Other
Also called Phase 3
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.
Oral Proprioceptive Stimulation Only (OPS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Baseline Condition (No Stimuli); Other: Auditory Stimulation only; Other: Auditory and Oral Proprioceptive Stimulation (OPS); Other: Oral Proprioceptive Stimulation Only (OPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 4-phase experimental protocol (single visit, approx. 45 minutes)
Secondary outcomes (2)
Elimination of Sound-Induced Visual Pseudo-Scotomas by Oral Proprioceptive Stimuli
Among participants who experienced VS during auditory stimulation alone, the presence or absence of VS was re-assessed during the combined application of auditory and oral proprioceptive stimuli to determine whether OPS could eliminate sound-induced visual disturbances.
Measured: Day 1, during phase 3 (auditory + OPS) of the experimental protocol
Presence of Visual Pseudo-Scotomas with Oral Proprioceptive Stimulation Alone
Participants were evaluated for the occurrence of visual pseudo-scotomas under oral proprioceptive stimuli without auditory input, to assess whether OPS alone could induce transient changes in visual perception.
Measured: Day 1, during phase 4 (OPS alone) of the experimental protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start16 Dec 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ProprioceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sophie Román Richon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Odontològic UB
- Responsible party
- Sponsor-investigator, Sophie Román Richon, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051460
- Sponsor's protocol ID
- CEIm HOUB 43/2022
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data (IPD) that might be shared include anonymized data on age, sex, inclusion/exclusion criteria, and responses related to the presence or absence of visual pseudo-scotomas during each phase of the experimental protocol. Data would be fully de-identified and shared only upon request, under appropriate ethical and legal conditions. At present, no final decision has been made regarding IPD sharing.
Publications
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.
PubMed 31308621Quercia 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.
PubMed 32103890
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTISENSORIALIDAD Y BOCA Estudio Del Efecto de estímulos Propioceptivos en el área estomatognática Sobre la percepción Visual, Con y Sin Sonido
- ClinicalTrials.gov ID
- NCT07051460
- Acronym / sponsor ID
- CEIm HOUB 43/2022
- Conditions
- Proprioception, Visual Perception, Multisensory, Stomatognathic System
- Keywords
- Proprioception, Multisensory Integration, Trigeminal Nerve, Visual Perception, Periodontal Mechanoreceptors, Stomatognathic System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sophie Román RichonUniversity, hospital or other
- Collaborators
- Hospital Odontològic UB
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Proprioception plays a well-established role in postural control and motor coordination, but increasing evidence supports its involvement in higher-level sensory processing, including spatial localization and multisensory integration. Given the anatomical overlap of trigeminal afferents innervating both oculomotor and orofacial structures, this study focused on the potential interplay between the stomatognathic and visual systems.
This study is an observational investigation with an experimental within-subject design with repeated measures in healthy volunteers.
The aim is to investigate the influence of oral proprioceptive stimuli on visual perception and audiovisual integration in healthy young adults, and explore whether non-invasive oral stimuli could modulate the occurrence of transient visual distortions-specifically Visual pseudo-Scotomas (VS)-when binocular vision is altered, and whether these stimuli could counteract the effects induced by auditory input.
Participants have been screened to ensure normal hearing, vision, and dental status, and underwent testing using the Vertical Maddox Test, which induces a dissociation in binocular vision that relies heavily on proprioceptive cues.
The experimental protocol was composed of four phases:
- Baseline evaluation with no stimuli.
- Application of auditory stimuli (500 Hz tones delivered through headphones) to assess their influence on visual perception.
- Application of simultaneous auditory and Oral Proprioceptive Stimuli (OPS), including both Combined Oral Stimuli (COS, such as specific tongue and lip positions) and Dental Stimuli (DS, consisting of gentle pressure/traction on central incisors using a calibrated probe).
- Application of Oral Proprioceptive Stimuli (OPS) alone, without sound.
Participants were asked to report the occurrence and location of any Visual pseudo-Scotomas (VS) observed during each phase. These were defined as functional visual field losses detected via the Vertical Maddox Test, with no underlying ocular pathology.
This protocol was developed based on prior work investigating ocular and oral proprioception and its role in multisensory integration. No pharmacological agents, devices, or therapeutic interventions were used. The study is observational in nature, and no biospecimens were collected or retained.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Other: Baseline Condition (No Stimuli), Other: Auditory Stimulation only, Other: Auditory and Oral Proprioceptive Stimulation (OPS), Other: Oral Proprioceptive Stimulation Only (OPS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- General criteria:
- Visual criteria:
- Dental criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline Condition (No Stimuli)Also: Phase 1Participants 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. | Other | Healthy adults |
| Auditory Stimulation onlyAlso: Phase 2Participants 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. | Other | Healthy adults |
| Auditory and Oral Proprioceptive Stimulation (OPS)Also: Phase 3Participants 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. | Other | Healthy adults |
| Oral Proprioceptive Stimulation Only (OPS)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. | Other | Healthy adults |
Primary outcome
Presence of Visual Pseudo-Scotomas (VS) under Auditory and/or Oral Proprioceptive Stimulation
Time frame: During 4-phase experimental protocol (single visit, approx. 45 minutes)
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.
2 secondary outcomes
Elimination of Sound-Induced Visual Pseudo-Scotomas by Oral Proprioceptive Stimuli
Time frame: Day 1, during phase 3 (auditory + OPS) of the experimental protocol
Presence of Visual Pseudo-Scotomas with Oral Proprioceptive Stimulation Alone
Time frame: Day 1, during phase 4 (OPS alone) of the experimental protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Results publication: PubMed 31308621Quercia 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.
- Results publication: PubMed 32103890Quercia 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.
- Individual participant dataSharing planned: Undecided. The individual participant data (IPD) that might be shared include anonymized data on age, sex, inclusion/exclusion criteria, and responses related to the presence or absence of visual pseudo-scotomas during each phase of the experimental protocol. Data would be fully de-identified and shared only upon request, under appropriate ethical and legal conditions. At present, no final decision has been made regarding IPD sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proprioception and Visual Perception, run by Sophie Román Richon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Visual Pseudo-Scotomas (VS) under Auditory and/or Oral Proprioceptive Stimulation (time frame: During 4-phase experimental protocol (single visit, approx. 45 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07051460, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.