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OpenTrials
Completed

NCT Number: NCT07737015

Effects of Respiratory Muscle Training on Tongue Corticomotor Excitability

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

IMT

Device

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.

EMT

Device

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.

Primary outcomes

  1. Motor-evoked potentials

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

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

Secondary outcomes

  1. Maximum Inspiratory and Expiratory Pressure

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

    Maximum Inspiratory and Expiratory pressure will be measured via the POWERBreathe device

  2. Tongue elevation peak pressure

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

    Tongue peak pressure during elevation movements will be measured via the IOPI device

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

Effects of a Short Bout of Respiratory Muscle Training on Tongue Corticomotor Excitability in Healthy Adults: A Pilot Study

Acronym: TMS-RMT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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