Invasive Mechanical VentilationNCT07842484
Measurement of Efferent Neural Drive From Respiratory Centers to Upper Airways Using Electromyography (EMG) of Genioglossus (GG) in Patients Dependent on Invasive Mechanical Ventilation
A study testing electromyography (EMG) of genioglossus (GG) in people with Invasive Mechanical Ventilation and Extubation Time, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Muscle activity in the upper airway is influenced by specific states such as anesthesia, sleep, wakefulness, and the phases of respiration. The hypoglossal nerve, which innervates the genioglossus muscle, receives input from the brain's sleep-wake center, respiratory pattern-generating neurons, chemoreceptors, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Mechanical Ventilation, Extubation Time
- What is being tested?
- electromyography (EMG) of genioglossus (GG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Dependent on invasive mechanical ventilation in ICU
- Awakening patient: improving neurological status (+2 points on the GCS compared to admission)
- Patient weaning from mechanical ventilation: presence of ventilator-recorded weaning trigger.
Who cannot join
- Known pregnancy
- Unstable intracranial pressure
- Pacemaker, internal defibrillator or pacing device wearers.
- Aneurysms at risk of rupture
- Severely impaired gas exchange despite optimal therapy
- GCS < 5 or clinical signs of poor prognosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Michele Pagani, MD, 0382502112, m.pagani@smatteo.pv.it
About this study
Muscle activity in the upper airway is influenced by specific states such as anesthesia, sleep, wakefulness, and the phases of respiration. The hypoglossal nerve, which innervates the genioglossus muscle, receives input from the brain's sleep-wake center, respiratory pattern-generating neurons, chemoreceptors, and airway negative pressure receptors. Preliminary activation of the genioglossus muscle and other upper airway dilators by the hypoglossal nerve occurs approximately 50-200 ms before innervation of the phrenic motor neurons and the subsequent action of the diaphragm. The forward movement of the genioglossus increases the stiffness and diameter of the upper airway, effectively counteracting collapse forces during inspiration. Assessing genioglossus function could prove critical in determining the optimal timing for extubation. This requires a methodology to evaluate the upper airway by measuring genioglossus activity in intubated patients. In the future, this could provide an objective measure for assessing suitability for extubation. This study explores a method for measuring the electrical activity of the upper airway muscles and the diaphragm in ventilated patients and correlates the results in a systematic view.
- Conditions
- Invasive Mechanical Ventilation, Extubation Time
- Being tested
- electromyography (EMG) of genioglossus (GG)
- Keywords
- genioglossus (GG) muscle activity, non-invasive EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromyography (EMG) of genioglossus (GG)Procedure or surgery
Measurement of efferent neural drive from respiratory centers to upper airways using electromyography (EMG) of genioglossus (GG) in patients dependent on invasive mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| patients dependent on invasive mechanical ventilation and extubation | Experimental | Not described Receives: Procedure: electromyography (EMG) of genioglossus (GG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
Measured: 6 months
Secondary outcomes (4)
Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).
Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).
Measured: 6 months
Change in GG-EMG amplitude from baseline to physiological challenge quantified as RMS or peak-to-peak
Change in GG-EMG amplitude from baseline to physiological challenge quantified as RMS or peak-to-peak
Measured: between Day 1 and Day 3 recordings
Change in GG-EMG amplitude between Day 1 and Day 3 recordings
Change in GG-EMG amplitude between Day 1 and Day 3 recordings
Measured: 1-3 days
Correlation of EMG metrics and clinical variables (e.g., sedation depth, PCO₂, neurological status)
Correlation of EMG metrics and clinical variables (e.g., sedation depth, PCO₂, neurological status)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Pagani, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842484
- Sponsor's protocol ID
- TONGUE-ICU
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Efferent Neural Drive From Respiratory Centers to Upper Airways Using Electromyography (EMG) of Genioglossus (GG) in Patients Dependent on Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07842484
- Acronym / sponsor ID
- TONGUE-ICU
- Conditions
- Invasive Mechanical Ventilation, Extubation Time
- Keywords
- genioglossus (GG) muscle activity, non-invasive EMG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Sep 2026 (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.
Muscle activity in the upper airway is influenced by specific states such as anesthesia, sleep, wakefulness, and the phases of respiration. The hypoglossal nerve, which innervates the genioglossus muscle, receives input from the brain's sleep-wake center, respiratory pattern-generating neurons, chemoreceptors, and airway negative pressure receptors. Preliminary activation of the genioglossus muscle and other upper airway dilators by the hypoglossal nerve occurs approximately 50-200 ms before innervation of the phrenic motor neurons and the subsequent action of the diaphragm. The forward movement of the genioglossus increases the stiffness and diameter of the upper airway, effectively counteracting collapse forces during inspiration. Assessing genioglossus function could prove critical in determining the optimal timing for extubation. This requires a methodology to evaluate the upper airway by measuring genioglossus activity in intubated patients. In the future, this could provide an objective measure for assessing suitability for extubation. This study explores a method for measuring the electrical activity of the upper airway muscles and the diaphragm in ventilated patients and correlates the results in a systematic view.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients dependent on invasive mechanical ventilation and extubation | Experimental | Procedure: electromyography (EMG) of genioglossus (GG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Dependent on invasive mechanical ventilation in ICU
- Awakening patient: improving neurological status (+2 points on the GCS compared to admission)
- Patient weaning from mechanical ventilation: presence of ventilator-recorded weaning trigger.
Key exclusion criteria (6 listed)
- Known pregnancy
- Unstable intracranial pressure
- Pacemaker, internal defibrillator or pacing device wearers.
- Aneurysms at risk of rupture
- Severely impaired gas exchange despite optimal therapy
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 |
|---|---|---|
| electromyography (EMG) of genioglossus (GG)Measurement of efferent neural drive from respiratory centers to upper airways using electromyography (EMG) of genioglossus (GG) in patients dependent on invasive mechanical ventilation | Procedure or surgery | patients dependent on invasive mechanical ventilation and extubation |
Primary outcome
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
Time frame: 6 months
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
4 secondary outcomes
Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).
Time frame: 6 months
Change in GG-EMG amplitude from baseline to physiological challenge quantified as RMS or peak-to-peak
Time frame: between Day 1 and Day 3 recordings
Change in GG-EMG amplitude between Day 1 and Day 3 recordings
Time frame: 1-3 days
Correlation of EMG metrics and clinical variables (e.g., sedation depth, PCO₂, neurological status)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electromyography (EMG) of genioglossus (GG) in people with Invasive Mechanical Ventilation and Extubation Time, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Sep 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.