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Not yet recruitingNCT07842484Updated Sep 25, 2026

Measurement of Efferent Neural Drive From Respiratory Centers to Upper Airways Using Electromyography (EMG) of Genioglossus (GG) in Patients Dependent on Invasive Mechanical Ventilation

An interventional study of electromyography (EMG) of genioglossus (GG) in Invasive Mechanical Ventilation and Extubation Time, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Other

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Invasive Mechanical Ventilation
  • Extubation Time

Keywords

  • genioglossus (GG) muscle activity
  • non-invasive EMG
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In context

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    patients dependent on invasive mechanical ventilation and extubation

    Procedure: electromyography (EMG) of genioglossus (GG)

Interventions

  • Procedureelectromyography (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

06

What researchers measure

Primary outcomes

  1. Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.

    Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.

    Time frame: 6 months

Secondary outcomes

  1. Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).

    Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).

    Time frame: 6 months

  2. 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

    Time frame: between Day 1 and Day 3 recordings

  3. Change in GG-EMG amplitude between Day 1 and Day 3 recordings

    Change in GG-EMG amplitude between Day 1 and Day 3 recordings

    Time frame: 1-3 days

  4. 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)

    Time frame: 6 months

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07842484
Responsible party
Michele Pagani (Principal Investigator, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 25, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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