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Swallowing DisordersNCT04706689

Development and Validation of the SWADOC Tool

An observational study of Swallowing Disorders and Dysphagia, run by University of Liege at 8 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: After a period of coma, patients with severe brain injury may present disorders of consciousness (DOC). A wide proportion of these patients also suffer from severe dysphagia. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SWADOC tool and FOTT-SAS
How many people
104 participants
Where
8 sitesin 2 countries
Study dates
24 Jul 2020to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

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: This study will be carried out in patients with DOC or emerging from DOC following severe acquired brain injury. Patients will be divided into four groups according to their clinical diagnosis assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs): UWS, MCS-, MCS+ and EMCS. Participants will be recruited from inpatient neurological rehabilitation programs in post-coma units and rehabilitation services, or hospitalized for an evaluation of multimodal assessment of consciousness for diagnostic and prognostic purposes. We will include 26 patients in each group, which will result in a total of 104 patients.

Who may be able to join

  • Age above 18-year-old
  • Perfect knowledge of French language before the injury
  • Previous event of coma phase caused by a severe acquired brain injury
  • Medical stability (absence of mechanical ventilation and sedation, no acute medical pathology such as infection or respiratory distress)
  • No neurological or otorhinolaryngological disease which can impact swallowing prior to the brain injury
  • Minimum of 28 days since the acquired brain injury at inclusion
Show all 9Show fewer
  • Diagnosis of UWS, MCS-, MCS+ or EMCS based on the CRS-R or SECONDs
  • Informed consent from legal representative of the patient
  • Affiliated patient or beneficiary of a health insurance plan (for French participants only).

Who cannot join

None listed.

Trial locations and contacts

8 sites in 2 countries.

Evelyne Mélotte, M.D. contact

00323663915

evelyne.melotte@chuliege.be

Marion Belorgeot, M.D. contact

marion.belorgeot@wanadoo.fr

8 sites in 2 countries

Belgium5 sites, 5 recruiting

  • Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz

    Fraiture, 4557

    Jenny Paluszkiewicz, jpaluszkiewicz@chuliege.be

    Recruiting

  • Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB)

    Jette

    Valérie Chavet, M.D., Valerie.Chavet@erasme.ulb.ac.be

    Elodie Guichard, M.D., Elodie.Guichard@erasme.ulb.ac.be

    Recruiting

  • Centre du Cerveau², University Hospital of Liège

    Liège, 4000

    Evelyne Mélotte, M.D., +323667248, evelyne.melotte@chuliege.be

    Olivia Gosseries, Ph.D., +3243663954, ogosseries@uliege.be

    Recruiting

  • Cliniques de Soins Spécialisés Valdor-Pèrî

    Liège, 4000

    Haroun Jedidi, M.D., haroun.jedidi@alumni.uliege.be

    Recruiting

  • Centre Hospitalier Neurologique William Lennox (UCL)

    Ottignies-Louvain-la-Neuve, Brabant Wallon, 1340

    Nicolas Lejeune, M.D., Ph.D., nicolas.lejeune@chnwl.be

    Recruiting

Other trials in Belgium

France3 sites, 3 recruiting

  • Fontfroide functional re-education centre

    Montpellier

    Jean-Baptiste Chevallier, +33 4 67 61 79 79, jeanbaptiste.chevallier@wanadoo.fr

    Recruiting

  • CHU Nîmes

    Nîmes

    Frederic Pellas, +33 4 66 68 38 56, frederic.pellas@chu-nimes.fr

    Not yet recruiting

  • Uzès hospital

    Uzès

    Valérie Dimanchin, +33 4 66 63 71 00, valerie.dimanchin@chuzes.fr

    Not yet recruiting

Other trials in France

About this study

Official title: The Development and Validation of the SWADOC Tool: A Study Protocol for a Multicentric Prospective Cohort Study

Background: After a period of coma, patients with severe brain injury may present disorders of consciousness (DOC). A wide proportion of these patients also suffer from severe dysphagia. Assessment and therapy of swallowing disabilities of DOC patients are essential because dysphagia has major functional consequences and comorbidities. Dysphagia evaluation in patients with DOC is hampered by the lack of adapted tools. The first aim of the study was to develop a new tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), and propose a validation protocol. The SWADOC tool has been developed to help therapists to apprehend components related to swallowing in patients with DOC. The second aim is to appreciate the relationship between patients' level of consciousness and SWADOC items and scores.

Method/design: In this multicentric prospective cohort, 104 patients with DOC will be tested three times during two consecutive days with the SWADOC tool. Statistical analyses will focus on the reliability and validity of the SWADOC tool, especially the intra and inter-rater reliability, internal consistency, measures of dispersion and concurrent validity with the FOTT Swallowing Assessment of Saliva (FOTT-SAS). The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R)

Discussion: The assessment of swallowing abilities among patients with DOC is the first necessary step towards the development of an individualized dysphagia care plan. A validated scoring tool will be essential for clinicians to better apprehend dysphagia in DOC patients and to document the evolution of their disorders.

Being tested
SWADOC tool, FOTT-SAS
Keywords
swallowing, dysphagia, disorders of consciousness, severe brain injury
Medical subject headings
Deglutition Disorders, Consciousness Disorders, Communication Disorders, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SWADOC toolBehavioural

    The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients.

    It is composed of an average of 50 qualitative items and a subsection named "SWADOC-scored" comprising 8 quantitative items.

  • FOTT-SASBehavioural

    Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required

Study groups in NCT04706689
Study groupRoleWhat they receive
Unresponsive wakefulness syndrome patients (UWS)The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
Receives: Behavioral: SWADOC tool; Behavioral: FOTT-SAS
Minimally conscious patients MINUS (MCS-)The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
Receives: Behavioral: SWADOC tool; Behavioral: FOTT-SAS
Minimally conscious patients PLUSThe level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
Receives: Behavioral: SWADOC tool; Behavioral: FOTT-SAS
Patients emerging from the minimally conscious state (EMCS)The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
Receives: Behavioral: SWADOC tool; Behavioral: FOTT-SAS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the SWADOC-scored during three sessions (Examiner 1) - Intra-reliability

    The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection "SWADOC-scored" includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24).

    The better the score is, the better the swallowing is.

    Measured: 15-25 minutes (3 times in 5 business days)

  2. SECONDs

    The Simplified Evaluation of CONsciousness Disorders (SECONDs): it features a shorter administration time (median of 7 minutes) and required only a mirror as material. It consists of 8 items: observation and reporting spontaneous behaviors, response to command, communication, visual pursuit and fixation, pain localization, oriented behaviors and arousal. The SECONDs provides a total score directly reflecting one diagnosis (0 = coma, 1 = UWS, 2-5 = MCS-, 6-7 = MCS+, 8 = EMCS). The better the score is, the better the consciousness level is.

    Measured: 7 minutes (immediately before or after the SWADOC tool in each of the three sessions)

Secondary outcomes (2)

  1. SWADOC-scored by Examiner 2 (inter-reliability)

    The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection "SWADOC-scored" includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24). The better the score is, the better the swallowing is.

    Measured: 15-25 minutes - immediately before or after one of the three sessions

  2. FOTT-SAS (Examiner 1)

    FOTT-SAS (Facial Oral Tract Therapy Swallowing Assessment of Saliva) The FOTT-SAS is a reliable assessment for detecting aspiration risk in patients with acquired brain injury.

    The test is based on 7 questions under which if items 1-4 are answered "Yes" and items 5-7 are answered "No", oral intake should be initiated (the better the score is, the better the swallowing is, minimum of 0, maximum of 7).

    The observations made during the assessment will permit to score the FOTT-SAS and verify the concurrent validity of the SWADOC tool.

    Measured: Immediately after one of the three sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start24 Jul 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706689
Sponsor's protocol ID
2020_79
Status last verified
Feb 2024
First submitted
7 Jan 2021
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Melotte E, Maudoux A, Delhalle S, Lagier A, Thibaut A, Aubinet C, Kaux JF, Vanhaudenhuyse A, Ledoux D, Laureys S, Gosseries O. Swallowing in individuals with disorders of consciousness: A cohort study. Ann Phys Rehabil Med. 2021 Jul;64(4):101403. doi: 10.1016/j.rehab.2020.04.008. Epub 2020 Jul 18.

    PubMed 32535170

  • Sanz LRD, Aubinet C, Cassol H, Bodart O, Wannez S, Bonin EAC, Barra A, Lejeune N, Martial C, Chatelle C, Ledoux D, Laureys S, Thibaut A, Gosseries O. SECONDs Administration Guidelines: A Fast Tool to Assess Consciousness in Brain-injured Patients. J Vis Exp. 2021 Feb 6;(168). doi: 10.3791/61968.

    PubMed 33616111

  • Mortensen J, Jensen D, Kjaersgaard A. A validation study of the Facial-Oral Tract Therapy Swallowing Assessment of Saliva. Clin Rehabil. 2016 Apr;30(4):410-5. doi: 10.1177/0269215515584381. Epub 2015 Apr 28.

    PubMed 25920675

  • Bicego A, Lejoly K, Maudoux A, Lefebvre P, Laureys S, Schweizer V, Diserens K, Faymonville ME, Vanhaudenhuyse A. [Swallowing in disorders of consciousness]. Rev Neurol (Paris). 2014 Oct;170(10):630-41. doi: 10.1016/j.neurol.2014.04.004. Epub 2014 Jun 18. French.

    PubMed 24952924

  • Wannez S, Gosseries O, Azzolini D, Martial C, Cassol H, Aubinet C, Annen J, Martens G, Bodart O, Heine L, Charland-Verville V, Thibaut A, Chatelle C, Vanhaudenhuyse A, Demertzi A, Schnakers C, Donneau AF, Laureys S. Prevalence of coma-recovery scale-revised signs of consciousness in patients in minimally conscious state. Neuropsychol Rehabil. 2018 Dec;28(8):1350-1359. doi: 10.1080/09602011.2017.1310656. Epub 2017 Apr 11.

    PubMed 28399715

  • Melotte E, Belorgeot M, Herr R, Simon J, Kaux JF, Laureys S, Sanz LRD, Lagier A, Morsomme D, Pellas F, Gosseries O. The Development and Validation of the SWADOC: A Study Protocol for a Multicenter Prospective Cohort Study. Front Neurol. 2021 Apr 29;12:662634. doi: 10.3389/fneur.2021.662634. eCollection 2021.

    PubMed 33995257

Questions about this trial

What is this clinical trial studying?

An observational study of Swallowing Disorders and Dysphagia, run by University of Liege at 8 sites in 2 countries.

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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Belgium, France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Evelyne Mélotte, M.D. (00323663915, evelyne.melotte@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the SWADOC-scored during three sessions (Examiner 1) - Intra-reliability (time frame: 15-25 minutes (3 times in 5 business days)). 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?

On the ClinicalTrials.gov record for NCT04706689, which also lists 6 linked publications.

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 22 Feb 2024.

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