Critical IllnessSIGNALNCT07076524
MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL)
An observational study of Critical Illness and Dysphagia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The goal of this study is to find out how muscle wasting in the mouth and throat affects swallowing (dysphagia) in adults who are critically ill and being treated in intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Dysphagia, Muscle Wasting in Critically Ill
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2025to 31 Jan 2028
- Phase
- Observational
- 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
Study population: Critically ill patients and non-critically ill patients
Who may be able to join
- Adults >18 years
- Receiving mechanical ventilation via endotracheal tube and/or tracheostomy. Expected to receive ventilation for at least 72 hours.
- Expected to survive admission and spend more than 7 days in the intensive care unit.
- Control participants
- Adults >18 years
- Receiving ward-based care.
- Expected to survive hospital admission. Present with a primary medical diagnosis of acute medical or surgical illness, not requiring critical care admission.
Who cannot join
- Applies to both critically ill and control participants.
- Pregnancy
- Patients with a diagnosis of a primary neuromuscular pathology (e.g., motor neurone disease), central nervous system disease (e.g., stroke, Guillain barre), traumatic brain injury, connective tissue disease (e.g., scleroderma), head and neck cancer, previous surgery or radiotherapy to the head and neck.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Hospital
London, E1 1FR
Eileen Kelly, +44 (0)20 3594 0351, eileen.kelly3@nhs.net
About this study
Official title: The Relationship Between Oral and Suprahyoid Muscle Wasting and Dysphagia in Critically Ill Patients
The goal of this study is to find out how muscle wasting in the mouth and throat affects swallowing (dysphagia) in adults who are critically ill and being treated in intensive care units.
The main aims of this research study are to understand: how much and how quickly the oral and suprahyoid muscles waste in critically ill participants, and whether muscle wasting causes problems with swallowing. The investigators will compare critically ill participants with non-critically ill participants to determine if muscle wasting is linked to swallowing problems.
Read more
In this study, participants will have the size and strength of their mouth and throat muscles measured at four different times during their critical care admission and hospital stay. Tests will also be performed to check how well and how safely participants can swallow. Tongue strength will be measured, and participants will answer questions about their experience with swallowing and eating using patient-reported outcome measures.
This study may help identify better ways to diagnose and treat swallowing problems in people who are critically ill, to support safe eating and drinking and promote faster recovery.
Read the detailed description
Background:
Dysphagia is a common and serious complication among critically ill patients admitted to intensive care units (ICUs). Up to 62% of patients who require mechanical ventilation experience dysphagia, which can lead to aspiration pneumonia, malnutrition, longer hospital stays, and increased mortality. Muscle wasting is a known consequence of critical illness and is associated with poor functional outcomes. The contribution of oral and suprahyoid muscle wasting to dysphagia in critically ill participants is poorly understood. This study aims to prospectively evaluate muscle wasting and its impact on swallowing function in critically ill adults.
Ethical Approval:
This study has Research Ethics Committee and Health Research Authority approval.
Study Objectives:
Primary Objective:
To measure the extent and rate of change in the cross-sectional area of the oral and suprahyoid muscles in critically ill adults using bedside ultrasound at four time points, and to relate these changes to swallowing physiology and safety.
Secondary Objectives:
To compare muscle mass and swallowing function between critically ill and non-critically ill participants.
To measure electrophysiological features of swallowing muscles using high-definition surface electromyography.
To assess patient-reported outcomes related to swallowing and eating.
To compare changes in the rectus femoris (thigh) muscle to those in the oral and suprahyoid muscles as a reference for general muscle wasting.
Study Design:
This is a prospective observational study. Critically ill participants admitted to the ICU will be recruited and compared with non-critically ill controls. The study includes repeated measures of muscle size and swallowing function over time.
Study Procedures:
Ultrasound Assessments:
The cross-sectional area of the tongue, geniohyoid, mylohyoid, and anterior belly of digastric muscles will be measured using bedside ultrasound at four time points during the participant's ICU stay. The rectus femoris muscle will also be measured as a reference for general muscle wasting.
Swallowing Evaluation:
Instrumental assessments of swallowing physiology and safety will be performed using gold standard assessments (e.g., videofluoroscopy or fiberoptic endoscopic evaluation of swallowing).
Tongue Strength:
Tongue strength will be measured using tongue dynamometry.
Electromyography:
High-definition surface electromyography will assess muscle activation patterns at rest and during swallowing.
Patient-Reported Outcomes:
Participants will complete patient reported outcome measures on swallowing, eating, and quality of life.
Data Management and Quality Assurance:
Data will be collected and managed according to Good Clinical Practice (GCP) and UK data protection regulations. Data will be collected using an online database (RedCap). Monitoring and auditing will be conducted by the sponsor to ensure protocol adherence and data integrity.
Sample Size and Statistical Analysis:
The sample size is calculated to detect clinically meaningful differences in muscle wasting and swallowing outcomes, based on expected rates in critically ill patients. Sample size was calculated based on a proof-of-conduct study completed by the investigators.
The primary analysis will use mixed-effects models to evaluate changes in muscle size and their association with swallowing function over time. Secondary analyses will compare critically ill patients with non-critically ill controls and explore associations between muscle wasting, swallowing outcomes, and patient-reported measures. Missing data will be addressed using appropriate statistical methods, such as multiple imputation or sensitivity analyses, as detailed in the statistical analysis plan.
Safety and Adverse Event Reporting:
The study involves only non-invasive assessments; risks are minimal and mainly relate to patient discomfort during swallowing tests. Adverse events and serious adverse events will be monitored and reported according to regulatory requirements.
Patient and Public Involvement:
Patients with experience of dysphagia in critical care contributed to the design of the study and the selection of outcome measures.
- Keywords
- dysphagia, critical illness, swallowing disorders, muscle wasting
- Medical subject headings
- Critical Illness, Deglutition Disorders, Muscular Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the extent and rate of muscle wasting
To measure the extent and rate of change in cross-sectional area of the oral and suprahyoid muscles in critically ill adults using bedside ultrasound across four time points. The extent and rate of muscle wasting will be assessed by measuring the change in cross-sectional area (mm²) of the oral and suprahyoid muscles using bedside ultrasound.
Measured: Day 1, 3, 7 and 10 of intensive care unit admission
Relate muscle wasting to swallow physiology and safety
To correlate changes in cross-sectional area to swallow physiology and safety in critically ill patients, using instrumental swallowing evaluations and tongue strength. To quantify the change in size of the oral and suprahyoid muscles, the cross-sectional area (mm²) will be measured using bedside ultrasound. Swallowing physiology and safety will be assessed using instrumental swallowing evaluations (e.g., Fiberoptic Endoscopic Evaluation of Swallowing (FEES)).The correlation coefficient (e.g., Pearson's or Spearman's r) between ultrasound-measured muscle cross-sectional area and instrumental swallowing assessment scores (e.g., the Penetration Aspiration Scale) will be used.
Measured: Following day 10 ultrasound or when the patient is extubated and clinically appropriate for swallow assessment
Secondary outcomes (7)
Measure electrophysiological features of swallow muscle activity
To measure the electrophysiological features of swallowing muscles using high definition surface electromyography in critically ill and non-critically ill patients. Electrophysiological features of swallowing-related muscles will be measured. Parameters will include average root mean square amplitude, symmetry of muscle activation, and duration of muscle activity during swallowing tasks.
Measured: Day 1, 3, 7 and 10 of intensive care unit admission
Compare relationship between muscle mass and swallow physiology
To compare the relationship between muscle mass and swallow physiology in critically ill patients and non-critically ill patients. The correlation between muscle mass and swallow physiology will be assessed. Muscle mass will be measured using ultrasound cross-sectional area (cm²) of the oral and suprahyoid muscles at four time points: Day 1, Day 3, Day 7, and Day 10 of ICU admission. Swallow physiology will be evaluated using instrumental evaluation (e.g., flexible endoscopic evaluation of swallow) and the following scales: Penetration-Aspiration Scale, Yale Pharyngeal Residue Severity Rating Scale and the Dynamic Imaging Grade of Swallow Toxicity) whichever occurs first, and when the patient is deemed clinically appropriate for assessment. The primary outcome will be the correlation coefficient (e.g., Pearson's or Spearman's r) between ultrasound-measured muscle mass (cm²) and swallow physiology scores.
Measured: Day 1, 3, 7 and 10 ultrasound assessments, swallow evaluation completed following day 10 ultrasound or when patient is extubated and clinically appropriate
Patient reported outcomes: Sydney Swallow Questionnaire
Patient-reported severity of dysphagia symptoms will be assessed using the Sydney Swallow Questionnaire (SSQ), with the total score ranging from 0 to 1700, where higher scores indicate greater symptom severity.
Measured: Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month
Patient reported outcomes: Swallowing Quality of Life (SWAL-QoL) Score
Patient-reported swallowing-related quality of life will be assessed using the Swallowing Quality of Life (SWAL-QoL) questionnaire, a 44-item instrument producing a total score from 0 to 100, where higher scores reflect better quality of life.
Measured: Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month
Patient reported outcomes: Functional Oral Intake Scale
Functional oral intake level will be measured using the Functional Oral Intake Scale (FOIS), a 7-point ordinal scale ranging from 1 (nothing by mouth) to 7 (total oral diet with no restrictions), where higher scores represent greater functional intake.
Measured: Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month
Patient reported outcomes: Eating Assessment Tool-10 (EAT-10)
Patient-reported dysphagia symptom burden will be screened using the Eating Assessment Tool-10 (EAT-10), a 10-item instrument with total scores ranging from 0 to 40, where scores of 3 or higher suggest abnormal swallowing.
Measured: Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month
Compare the extent of muscle wasting in critically ill versus non-critically ill patient
To measure and compare the extent and rate of change in cross-sectional area of the rectus-femoris muscle and the oral and supra-hyoid muscles using bedside ultrasound across four time points.
Measured: Day 1, 3, 7 and 10 ultrasound evaluation vs single timepoint in non-critically ill patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076524
- Sponsor's protocol ID
- 348596
- Other IDs
- G-002784
- Acronym
- SIGNAL
- Status last verified
- Nov 2025
- First submitted
- 22 May 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Oral and Suprahyoid Muscle Wasting and Dysphagia in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07076524
- Acronym / sponsor ID
- SIGNAL / 348596
- Keywords
- dysphagia, critical illness, swallowing disorders, muscle wasting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 22 Jul 2025 (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.
The goal of this study is to find out how muscle wasting in the mouth and throat affects swallowing (dysphagia) in adults who are critically ill and being treated in intensive care units.
The main aims of this research study are to understand: how much and how quickly the oral and suprahyoid muscles waste in critically ill participants, and whether muscle wasting causes problems with swallowing. The investigators will compare critically ill participants with non-critically ill participants to determine if muscle wasting is linked to swallowing problems.
In this study, participants will have the size and strength of their mouth and throat muscles measured at four different times during their critical care admission and hospital stay. Tests will also be performed to check how well and how safely participants can swallow. Tongue strength will be measured, and participants will answer questions about their experience with swallowing and eating using patient-reported outcome measures.
This study may help identify better ways to diagnose and treat swallowing problems in people who are critically ill, to support safe eating and drinking and promote faster recovery.
Detailed description
Background:
Dysphagia is a common and serious complication among critically ill patients admitted to intensive care units (ICUs). Up to 62% of patients who require mechanical ventilation experience dysphagia, which can lead to aspiration pneumonia, malnutrition, longer hospital stays, and increased mortality. Muscle wasting is a known consequence of critical illness and is associated with poor functional outcomes. The contribution of oral and suprahyoid muscle wasting to dysphagia in critically ill participants is poorly understood. This study aims to prospectively evaluate muscle wasting and its impact on swallowing function in critically ill adults.
Ethical Approval:
This study has Research Ethics Committee and Health Research Authority approval.
Study Objectives:
Primary Objective:
To measure the extent and rate of change in the cross-sectional area of the oral and suprahyoid muscles in critically ill adults using bedside ultrasound at four time points, and to relate these changes to swallowing physiology and safety.
Secondary Objectives:
To compare muscle mass and swallowing function between critically ill and non-critically ill participants.
To measure electrophysiological features of swallowing muscles using high-definition surface electromyography.
To assess patient-reported outcomes related to swallowing and eating.
To compare changes in the rectus femoris (thigh) muscle to those in the oral and suprahyoid muscles as a reference for general muscle wasting.
Study Design:
This is a prospective observational study. Critically ill participants admitted to the ICU will be recruited and compared with non-critically ill controls. The study includes repeated measures of muscle size and swallowing function over time.
Study Procedures:
Ultrasound Assessments:
The cross-sectional area of the tongue, geniohyoid, mylohyoid, and anterior belly of digastric muscles will be measured using bedside ultrasound at four time points during the participant's ICU stay. The rectus femoris muscle will also be measured as a reference for general muscle wasting.
Swallowing Evaluation:
Instrumental assessments of swallowing physiology and safety will be performed using gold standard assessments (e.g., videofluoroscopy or fiberoptic endoscopic evaluation of swallowing).
Tongue Strength:
Tongue strength will be measured using tongue dynamometry.
Electromyography:
High-definition surface electromyography will assess muscle activation patterns at rest and during swallowing.
Patient-Reported Outcomes:
Participants will complete patient reported outcome measures on swallowing, eating, and quality of life.
Data Management and Quality Assurance:
Data will be collected and managed according to Good Clinical Practice (GCP) and UK data protection regulations. Data will be collected using an online database (RedCap). Monitoring and auditing will be conducted by the sponsor to ensure protocol adherence and data integrity.
Sample Size and Statistical Analysis:
The sample size is calculated to detect clinically meaningful differences in muscle wasting and swallowing outcomes, based on expected rates in critically ill patients. Sample size was calculated based on a proof-of-conduct study completed by the investigators.
The primary analysis will use mixed-effects models to evaluate changes in muscle size and their association with swallowing function over time. Secondary analyses will compare critically ill patients with non-critically ill controls and explore associations between muscle wasting, swallowing outcomes, and patient-reported measures. Missing data will be addressed using appropriate statistical methods, such as multiple imputation or sensitivity analyses, as detailed in the statistical analysis plan.
Safety and Adverse Event Reporting:
The study involves only non-invasive assessments; risks are minimal and mainly relate to patient discomfort during swallowing tests. Adverse events and serious adverse events will be monitored and reported according to regulatory requirements.
Patient and Public Involvement:
Patients with experience of dysphagia in critical care contributed to the design of the study and the selection of outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients and non-critically ill patients
Key inclusion criteria (7 listed)
- Adults >18 years
- Receiving mechanical ventilation via endotracheal tube and/or tracheostomy. Expected to receive ventilation for at least 72 hours.
- Expected to survive admission and spend more than 7 days in the intensive care unit.
- Control participants
- Adults >18 years
Key exclusion criteria (3 listed)
- Applies to both critically ill and control participants.
- Pregnancy
- Patients with a diagnosis of a primary neuromuscular pathology (e.g., motor neurone disease), central nervous system disease (e.g., stroke, Guillain barre), traumatic brain injury, connective tissue disease (e.g., scleroderma), head and neck cancer, previous surgery or radiotherapy to the head and neck.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the extent and rate of muscle wasting
Time frame: Day 1, 3, 7 and 10 of intensive care unit admission
To measure the extent and rate of change in cross-sectional area of the oral and suprahyoid muscles in critically ill adults using bedside ultrasound across four time points. The extent and rate of muscle wasting will be assessed by measuring the change in cross-sectional area (mm²) of the oral and suprahyoid muscles using bedside ultrasound.
Relate muscle wasting to swallow physiology and safety
Time frame: Following day 10 ultrasound or when the patient is extubated and clinically appropriate for swallow assessment
To correlate changes in cross-sectional area to swallow physiology and safety in critically ill patients, using instrumental swallowing evaluations and tongue strength. To quantify the change in size of the oral and suprahyoid muscles, the cross-sectional area (mm²) will be measured using bedside ultrasound. Swallowing physiology and safety will be assessed using instrumental swallowing evaluations (e.g., Fiberoptic Endoscopic Evaluation of Swallowing (FEES)).The correlation coefficient (e.g., Pearson's or Spearman's r) between ultrasound-measured muscle cross-sectional area and instrumental swallowing assessment scores (e.g., the Penetration Aspiration Scale) will be used.
7 secondary outcomes
Measure electrophysiological features of swallow muscle activity
Time frame: Day 1, 3, 7 and 10 of intensive care unit admission
Compare relationship between muscle mass and swallow physiology
Time frame: Day 1, 3, 7 and 10 ultrasound assessments, swallow evaluation completed following day 10 ultrasound or when patient is extubated and clinically appropriate
Patient reported outcomes: Sydney Swallow Questionnaire
Time frame: Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month
Patient reported outcomes: Swallowing Quality of Life (SWAL-QoL) Score
Time frame: Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month
Patient reported outcomes: Functional Oral Intake Scale
Time frame: Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month
Patient reported outcomes: Eating Assessment Tool-10 (EAT-10)
Time frame: Within two weeks of day 10 ultrasound measurement or when clinically appropriate (e.g., ICU delirium resolved if present), up to 1 month
Compare the extent of muscle wasting in critically ill versus non-critically ill patient
Time frame: Day 1, 3, 7 and 10 ultrasound evaluation vs single timepoint in non-critically ill patients
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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Critical Illness and Dysphagia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 United Kingdom. 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?
Measure the extent and rate of muscle wasting (time frame: Day 1, 3, 7 and 10 of intensive care unit admission). The study lists 2 primary outcomes in all. 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 18 Nov 2025.