Effectiveness of Transcutaneous NMES as an Adjunct for Swallowing Disorders in Tracheotomized Patients (SWALEC)

April 9, 2026 updated by: Hopital Forcilles

Evaluation of the Effectiveness of Transcutaneous Neuromuscular Electrical Stimulation as an Adjunct to Standard Treatment for Swallowing Disorders in Tracheotomized Patients Following Prolonged Mechanical Ventilation Weaning

Dysphagia can reach a prevalence of up to 80% in intensive care patients. The implementation or prolonged presence of medical devices such as the intubation tube, tracheostomy, or nasogastric tube alters the physiology of swallowing and causes local injuries at several levels. Additionally, certain medical treatments impair swallowing physiology and the patient's alertness, further promoting the development of these disorders.

Management of dysphagia involves two main types of strategies: adaptive or compensatory maneuvers and rehabilitation techniques such as: performing praxis or swallowing exercises; physical stimulation (tactile or thermal); transcranial stimulation (electrical or magnetic); and finally, pharyngeal or transcutaneous electrical stimulation (NMES).

Patients hospitalized in intensive care often present with altered levels of alertness, asynchronous ventilation and swallowing, and reduced motor capabilities, making it difficult to perform techniques like praxis, food trials, or resistance swallowing exercises. NMES does not require active patient cooperation or the permanent presence of the therapist during the stimulation session, thus increasing the intensity of dysphagia rehabilitation and the early implementation of treatment in these patients, complementing conventional rehabilitation. Muscle and sensory stimulation through the application of NMES can help increase the strength of the muscles involved in swallowing and improve sensory capabilities. However, its effects have not yet been evaluated in tracheostomized patients undergoing weaning from prolonged mechanical ventilation.

Study Overview

Status

Status

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Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized in intensive care units, post-ICU rehabilitation, or weaning and rehabilitation services;
  • Presence of a tracheostomy for more than 72 hours due to difficult mechanical ventilation weaning;
  • Diagnosis of swallowing disorders (swallowing fiberoscopy);
  • Patient aged at least 18 years at the time of inclusion;
  • Affiliated to a social security scheme or beneficiary of such a scheme;
  • Written, free and informed consent of the patient or their next of kin.

Exclusion Criteria:

  • Contra- indication to cervical NMES;
  • History of swallowing disorders;
  • Patient with a spinal cord injury above C5 level;
  • History of head and neck cancer;
  • Person under legal protection measures;
  • Patient under guardianship or conservatorship;
  • Known pregnancy;
  • Limitation of care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Neuromuscular Electrical Stimulation (Placebo NMES)
Patients included in the control group will receive standard care and the control intervention. The Neuro Muscular Electrical Stimulation (NMES) will be applied through 2 pairs of electrodes to the anterior surface of the neck. The same frequency and pulse duration will be used. The intensity will be increased until a vibration/tingling sensation perceptible by the patient is produced. The device will then be turned off.
Procedure: Placebo Neuromuscular Electrical Stimulation (Placebo NMES)

NMES will be applied via two pairs of electrodes on the anterior neck.

Two electrodes will be placed above the hyoid bone, on either side, between the hyoid bone and the mandible. The other two electrodes will be placed on either side of the thyroid cartilage.

The patient will also be comfortably positioned in a supine position, with the backrest inclined at 45°. The same frequency and pulse duration will be used. The intensity will be increased until the patient perceives a vibrating/tingling sensation. The device will then be turned off.

The control intervention begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, five days per week.

The treatment is administered once per day at a time slot chosen by each center.
Experimental: Neuromuscular Electrical Stimulation (NMES)

The patient is comfortably positioned on their back, with the backrest at a 45° incline. Neuromuscular electrical stimulation (NMES) is applied through two pairs of electrodes placed on the front of the neck: one pair on the supra-hyoid muscles and the other on the infra-hyoid muscles. The electrodes are positioned using anatomical landmarks of the hyoid bone and the mandible. A current of 80 Hz with a pulse duration of 700 µs is applied to induce a muscle contraction. The treatment begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, 5 days a week. The treatment is performed once per day.

Let me know if you need further adjustments or explanations!
Procedure: Neuromuscular Electrical Stimulation (NMES)

The patient will be comfortably positioned on their back, with the backrest inclined at 45°.

NMES will be applied via two pairs of electrodes on the anterior neck. One pair of electrodes will be placed on the suprahyoid muscles and the other on the infrahyoid muscles.

The treatment begins at least 72 hours after the tracheotomy and lasts for 21 days, with daily 30-minute sessions, five days per week. The treatment is administered once per day. Each department is encouraged to identify a time slot to facilitate the organization of care and avoid non-completion of the treatment.

The duration of the session and the frequency of the intervention's application were chosen based on data from a recent systematic review of randomized controlled trials comparing the effectiveness of NMES versus conventional treatment. The included studies mostly had session durations around 30 minutes, 2 to 5 times per week, for a period of 2 to 6 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of swallowing disorders after 21 days of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments, in patients following tracheotomy due to prolonged mechanical ventilation weaning
Time Frame: after 21 days of treatment
Evaluate the effectiveness of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments for swallowing disorders, on the prevalence of these disorders after 21 days of treatment, in patients who have undergone tracheotomy due to prolonged mechanical ventilation weaning.
after 21 days of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of swallowing disorders - the yale pharyngeal residue severity rating scale
Time Frame: 21 days
Comparatively evaluate the effectiveness of NMES of the suprahyoid and infrahyoid muscles as an adjunct to standard treatments for swallowing disorders in patients who have undergone tracheotomy due to prolonged mechanical ventilation weaning on the severity of swallowing disorders at 21 days of NMES as an adjunct to standard treatments, in patients following tracheotomy. Unit of Measure: the yale pharyngeal residue severity rating scale rated by a speech-language therapist based on fiberoptic endoscopic evaluation of swallowing (FEES). This assessments by a speech-language therapist blinded to group allocation.
21 days
Time to resume oral feeding at Day 21 after NMES initiation
Time Frame: At day 21 after initiation of NMES/placebo

Description:

Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on time to resume oral feeding within 21 days in tracheotomized patients following prolonged mechanical ventilation weaning. Time will be measured in days. In routine practice, all changes in the patient's dietary intake are recorded daily by medical, dietitians and nursing staff. Data collected from the patient's electronic medical record by a clinical research technician.
At day 21 after initiation of NMES/placebo
Duration of mechanical ventilation
Time Frame: Day 21 after initiation of NMES treatment/placebo
Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on the duration of mechanical ventilation. Data collected from the patient's electronic medical record by a clinical research technician.
Day 21 after initiation of NMES treatment/placebo
Lenght of stay
Time Frame: From study inclusion (Day 0) until discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days)
Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on length of stay in the intensive care unit. Length of stay will be measured in days and collected from the electronic medical records by a trained clinical research technician.
From study inclusion (Day 0) until discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days)
Time to tracheostomy decannulation
Time Frame: From study inclusion (Day 0) until tracheostomy decannulation, assessed up to study completion (approximately 30 days)
Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on time to tracheotomy decannulation. Time will be measured in days. Data will be collected from the electronic medical records by a trained clinical research technician.
From study inclusion (Day 0) until tracheostomy decannulation, assessed up to study completion (approximately 30 days)
Prevalence of malnutrition
Time Frame: At day 21 after initiation NMES treament/place
Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on the prevalence of malnutrition at Day 21. Prevalence of malnutrition will be expressed as a percentage of patients meeting predefined diagnostic criteria (French national recommendations on malnutrition diagnostic evaluation)
At day 21 after initiation NMES treament/place
Prevalence of malnutrition at unit discharge
Time Frame: At study end, defined as discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days)
Comparative evaluation of the effectiveness of neuromuscular electrical stimulation (NMES) of the suprahyoid and infrahyoid muscles, as an adjunct to standard care, on the prevalence of malnutrition at unit discharge. Prevalence of malnutrition will be expressed as a percentage of patients meeting predefined diagnostic criteria (French national recommendations on malnutrition diagnostic evaluation)
At study end, defined as discharge from the intensive care unit or post-intensive care unit, assessed up to study completion (approximately 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Forcilles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlos Diaz Lopez, Hopital Forcilles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-A01576-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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