NCT07737015

Brief Summary

The tongue plays a central role in essential oral functions, including swallowing, speech, and upper airway control. Its coordinated interaction with the respiratory system is particularly relevant in clinical conditions such as obstructive sleep apnea and dysphagia. While respiratory muscle training is increasingly used in these contexts, its effects on the neural control of tongue function remain poorly understood. This randomized cross-over pilot study aimed to investigate the acute effects of inspiratory (IMT) and expiratory (EMT) muscle training on tongue corticomotor excitability using transcranial magnetic stimulation. These results will provide novel insight into the neurophysiological mechanisms linking respiratory interventions and oral motor control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 25, 2026

Last Update Submit

July 25, 2026

Conditions

Keywords

Transcranial magnetic stimulationtonguemotor-evoked potentialsrespiratory muscle trainingcorticomotor excitability

Outcome Measures

Primary Outcomes (1)

  • Motor-evoked potentials

    The amplitude of tongue-related motor-evoked potentials are assessed using transcranial magnetic stimulation over the tongue motor cortex.

    Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)

Secondary Outcomes (2)

  • Maximum Inspiratory and Expiratory Pressure

    Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)

  • Tongue elevation peak pressure

    Measured two times: immediately before the training session (baseline) and immediately after completion of the training session (approximately 45 minutes after baseline)

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

Participants will perform a short term session of inspiratory muscle training, using an adjustable external load.

Device: IMT

Expiratory muscle training

EXPERIMENTAL

Participants will perform a short term session of expiratory muscle training, using an adjustable external load

Device: EMT

Interventions

IMTDEVICE

An inspiratory threshold loading device set at 50% of the baseline maximal inspiratory pressure (PImax) was used. The training session consisted of five cycles of 20 breaths performed against the device, with a 2-minute rest period between cycles. Each breath consisted of quiet exhalation through the device, followed by a deep and forceful inspiration against the prescribed load.

Inspiratory Muscle Training
EMTDEVICE

An expiratory threshold loading device set at 50% of the baseline maximal expiratory pressure (PEmax) was used. The training session consisted of five cycles of 20 breaths performed against the device, with a 2-minute rest period between cycles. Each breath consisted of quiet inhalation through the device, followed by a deep and forceful expiration against the set load.

Expiratory muscle training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • good general health
  • ability to read and understand the project information

You may not qualify if:

  • medical, physical or psychological disorder
  • metal implants in the head
  • medications affecting the nervous system
  • craniofacial abnormalities
  • neuromuscular or inflammatory diseases
  • history of epilepsy
  • presence of pacemaker or implanted medical devices
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor

Study Record Dates

First Submitted

July 25, 2026

First Posted

July 30, 2026

Study Start

October 1, 2024

Primary Completion

December 6, 2024

Study Completion

December 6, 2024

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations