NCT06790459

Brief Summary

Pupil size is associated with the activity of the noradrenergic system, with an increase reflecting a higher state of arousal. Transmucosal electrical stimulation of the tongue could treat disorders related to dysfunctions of this system, and trigeminal stimulation through ULFTENS (TUD) has shown some positive effects. However, no studies have examined the effect of stimulation of the anterior mucosa of the tongue on pupil size as an indicator of arousal. The aim of this study will be to evaluate the effect of ULFTENS stimulation on pupil size in the dark.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

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

September 24, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

8 days

First QC Date

January 16, 2025

Last Update Submit

January 21, 2025

Conditions

Pupil DiameterArousal

Keywords

Pupil sizeULFTENSTrigeminal electrical stimulationtongue stimulation

Outcome Measures

Primary Outcomes (1)

  • Pupil size

    left and right pupils diameter will be measured using a pupillometry. Images of the pupils will be acquired by the Oculus system, using two infrared CCD cameras (resolution 720 × 576 pixels, 256 grey levels) mounted on a light helmet (1.5 kg), with sampling frequency of 25 frame/s. The eyes will be illuminated with an infrared diode with 880 nm of wave length.

    12 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

20 women of 20-30 years would be enrolled to the experimental group. They will undergone to tongue stimulation with ULFTENS device for 15 minutes. Pupils' diameter will be measure for three time points, before, during and after the tongue stimulation

Device: UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)

Control group

NO INTERVENTION

20 women of 20-30 years will be enrolled to the control group. Their pupils' diameter will be measure at three time points

Interventions

UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)DEVICE

ULFTENS device will be administered in the experimental group for 15 minutes

Experimental group

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good health status and physical fitness
  • female sex
  • age between 20 and 30 years
  • non-smoker
  • no more than 3 espresso coffees per day
  • no intake of stimulant or psychotropic drugs in general
  • body mass index between 18.5 and 24.9

You may not qualify if:

  • presence of acute and/or chronic cardiocirculatory and respiratory disorders
  • metabolic and autonomic system disorders
  • intake of peripheral and central nervous system excitatory or inhibiting substances
  • presence of generalized anxiety and/or panic attacks, or mood disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinic, Mesva department

L’Aquila, Italia, 67100, Italy

Location

Related Publications (2)

  • Monaco A, Cattaneo R, Smurra P, Di Nicolantonio S, Cipriano F, Pietropaoli D, Ortu E. Trigeminal electrical stimulation with ULFTENS of the dorsal anterior mucosal surface of the tongue: Effects on Heart Rate Variability (HRV). PLoS One. 2023 May 10;18(5):e0285464. doi: 10.1371/journal.pone.0285464. eCollection 2023.

    PMID: 37163499RESULT

  • Monaco A, Cattaneo R, Di Nicolantonio S, Strada M, Pietropaoli D, Ortu E. Effects of trigeminal neurostimulation on heart rate variability: comparing cutaneous (Tragus) and tongue (Antero-Dorsal mucosa) stimulation. BMC Oral Health. 2024 Oct 20;24(1):1257. doi: 10.1186/s12903-024-04914-2.

    PMID: 39428464RESULT

Study Officials

  • Annalisa Monaco

    University of L'Aquila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 24, 2025

Study Start

September 24, 2024

Primary Completion

October 2, 2024

Study Completion

October 30, 2024

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)