DysphagiaDESIRENCT02960737
Dysphagia Evaluation After Stroke- Effect Oral Neuromuscular Training on Swallowing Dysfunction
A study testing Oral neuromuscular training using an oral device in people with Dysphagia and Stroke, run by Umeå University at 1 site in Sweden.
Trial summary
The aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Oral neuromuscular training using an oral device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2022to Mar 2029
- 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
- Persistent dysphagia 12(±3) weeks after STROKE.
Who cannot join
- Stroke patients with neurologic or psychiatric disorders or other diseases/conditions that can affect swallowing function.
- Unable to collaborate due to other serious diseases and/or to affected general condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
University Hospital of Umeå
Umeå
Patricia Hägglund, PhD, patricia.hagglund@umu.se
About this study
Official title: Dysphagia Evaluation After Stroke - a Randomized Controlled Trial of Oral Neuromuscular Training on Swallowing Dysfunction (DESIRE)
The aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia.
Read the detailed description
This study aims to investigate the effect of oral neuromuscular training in stroke patients with persistent oral- and pharyngeal dysphagia 12 (±3) weeks after stroke onset.
Interventional study with PROBE-design (prospective randomized open-label blinded evaluator). Consecutive patients with first-ever stroke without previously known dysphagia with persistent dysphagia (DOSS<6) at 3 months (12±3 weeks) post-stroke onset. Patients are eligible to participate if they are admitted to one of the following seven hospitals/centers in Sweden: Umeå University Hospital, Danderyds Hospital, Södersjukhuset, Skaraborg Hospital (Skövde), Helsingborg Hospital, Halland Hospital, Kungälv Hospital, Kalix Hospital, Skellefteå Hospital, and Ellenbogen in Malmö. Further centers will be recruited. Exclusion criteria: Unable/unwilling to give informed consent or to cooperate.
Randomization will be made web-based 1:1 by use of the developed REDCap system with stratification for center and aspiration (yes/no).
In total, 336 stroke patients (168 intervention group; 168 control group) with persistent dysphagia 12(±3) weeks after stroke onset will be included in the present study. The intervention group will be offered to undergo oral neuromuscular training alongside routine care with compensatory training for 3 months. The control group will only be offered routine care with compensatory training for 3 months.
The participants' status regarding swallowing function, nutritional status, quality of life related to swallowing, pneumonia, functional status including lip force, and death will be assessed before and after the completed intervention period, and 6 months post-intervention.
The primary endpoint will be analyzed using an ordinal regression (proportional odds) model, adjusting for baseline DOSS as well as for the stratifying variables center and aspiration.
The investigators hypothesize that swallowing intervention with oral neuromuscular training is more effective than routine care rehabilitation.
- Being tested
- Oral neuromuscular training using an oral device
- Keywords
- Dysphagia, Stroke, Intervention, Oral neuromuscular training, Randomized control trial
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral neuromuscular training using an oral deviceDevice
The oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intensive training with oral neuromuscular training using an oral device (intervention group) and routine care with compensatory swallowing training under 3 months with start 12 (±3) weeks after stroke onset. Receives: Device: Oral neuromuscular training using an oral device |
| Control group | No intervention | Routine care with compensatory swallowing training under 3 months with starting 12 (±3) weeks after stroke onset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing Function
Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)
Measured: At start compared with at end of treatment (after 3 months)
Secondary outcomes (8)
Swallowing function
Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)
Measured: At start and 6 months post-intervention
Lip-force (LF)
Change in lip-force measured in newtons (N) with the Lip Force Meter LF100.
Measured: At start, at end of treatment (after 3 months) and 6 months post-intervention
Swallowing Quality of Life Questionnaire (SWAL-QOL)
Change in quality of life related to swallowing measured by the SWAL-QOL questionnaire.
Measured: At start, at end of treatment (after 3 months) and 6 months post-intervention
Nutritional status
Change in nutritional status measured with the Mini Nutritional Assessment (MNA).
Measured: At start, at end of treatment (after 3 months) and 6 months post-intervention
Activity of daily living (ADL)
Change in activity of daily living (ADL) measured by Barthels Index (BI).
Measured: At start, at end of treatment (after 3 months) and 12-18 months post-intervention
Global disability
Change in global disability measured with modified Rankin Scale (mRS)
Measured: At start, at end of treatment (after 3 months) and 6 months post-intervention
Aspiration-pneumonia
Change in rate of aspiration-pneumonia based on the modified criteria by Centers for Disease Control and Prevention (CDC) for stroke-associated pneumonia
Measured: At start, at end of treatment (after 3 months) and 6 months post-intervention
Death
Change in rate of death
Measured: At start, at end of treatment (after 3 months) and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start1 Dec 2022
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Umeå
- Responsible party
- Sponsor
- Investigators
- Patricia Hägglund, PhD/SLP, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960737
- Sponsor's protocol ID
- 2015-319-31M
- Acronym
- DESIRE
- Status last verified
- May 2026
- First submitted
- 8 Jul 2016
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagglund P, Bergstrom L, Forsgren J, Holmlund T, Liv P, Levring Jaghagen E, Mirkoska V, Romanitan M, Selg J, Wester P. Dysphagia Evaluation after Stroke through Intervention with oral neuromuscular training for REhabilitation of swallowing dysfunction (DESIRE): study protocol for a multicenter randomized controlled trial. Trials. 2026 May 19;27(1):381. doi: 10.1186/s13063-026-09778-1.
PubMed 42157318
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia Evaluation After Stroke - a Randomized Controlled Trial of Oral Neuromuscular Training on Swallowing Dysfunction (DESIRE)
- ClinicalTrials.gov ID
- NCT02960737
- Acronym / sponsor ID
- DESIRE / 2015-319-31M
- Keywords
- Dysphagia, Stroke, Intervention, Oral neuromuscular training, Randomized control trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Umeå
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 10 Nov 2016 (estimated)
- 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 aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia.
Detailed description
This study aims to investigate the effect of oral neuromuscular training in stroke patients with persistent oral- and pharyngeal dysphagia 12 (±3) weeks after stroke onset.
Interventional study with PROBE-design (prospective randomized open-label blinded evaluator). Consecutive patients with first-ever stroke without previously known dysphagia with persistent dysphagia (DOSS<6) at 3 months (12±3 weeks) post-stroke onset. Patients are eligible to participate if they are admitted to one of the following seven hospitals/centers in Sweden: Umeå University Hospital, Danderyds Hospital, Södersjukhuset, Skaraborg Hospital (Skövde), Helsingborg Hospital, Halland Hospital, Kungälv Hospital, Kalix Hospital, Skellefteå Hospital, and Ellenbogen in Malmö. Further centers will be recruited. Exclusion criteria: Unable/unwilling to give informed consent or to cooperate.
Randomization will be made web-based 1:1 by use of the developed REDCap system with stratification for center and aspiration (yes/no).
In total, 336 stroke patients (168 intervention group; 168 control group) with persistent dysphagia 12(±3) weeks after stroke onset will be included in the present study. The intervention group will be offered to undergo oral neuromuscular training alongside routine care with compensatory training for 3 months. The control group will only be offered routine care with compensatory training for 3 months.
The participants' status regarding swallowing function, nutritional status, quality of life related to swallowing, pneumonia, functional status including lip force, and death will be assessed before and after the completed intervention period, and 6 months post-intervention.
The primary endpoint will be analyzed using an ordinal regression (proportional odds) model, adjusting for baseline DOSS as well as for the stratifying variables center and aspiration.
The investigators hypothesize that swallowing intervention with oral neuromuscular training is more effective than routine care rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Oral neuromuscular training using an oral deviceIntensive training with oral neuromuscular training using an oral device (intervention group) and routine care with compensatory swallowing training under 3 months with start 12 (±3) weeks after stroke onset. |
| Control group | No intervention | –Routine care with compensatory swallowing training under 3 months with starting 12 (±3) weeks after stroke onset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persistent dysphagia 12(±3) weeks after STROKE.
Key exclusion criteria (2 listed)
- Stroke patients with neurologic or psychiatric disorders or other diseases/conditions that can affect swallowing function.
- Unable to collaborate due to other serious diseases and/or to affected general condition.
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 |
|---|---|---|
| Oral neuromuscular training using an oral deviceThe oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles. | Device | Intervention group |
Primary outcome
Swallowing Function
Time frame: At start compared with at end of treatment (after 3 months)
Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)
8 secondary outcomes
Swallowing function
Time frame: At start and 6 months post-intervention
Lip-force (LF)
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Swallowing Quality of Life Questionnaire (SWAL-QOL)
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Nutritional status
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Activity of daily living (ADL)
Time frame: At start, at end of treatment (after 3 months) and 12-18 months post-intervention
Global disability
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Aspiration-pneumonia
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Death
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
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 8 May 2026.
- Derived from this study: PubMed 42157318Hagglund P, Bergstrom L, Forsgren J, Holmlund T, Liv P, Levring Jaghagen E, Mirkoska V, Romanitan M, Selg J, Wester P. Dysphagia Evaluation after Stroke through Intervention with oral neuromuscular training for REhabilitation of swallowing dysfunction (DESIRE): study protocol for a multicenter randomized controlled trial. Trials. 2026 May 19;27(1):381. doi: 10.1186/s13063-026-09778-1.
- Individual participant dataSharing planned: No
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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.
Patricia Hägglund, PhD/SLP principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral neuromuscular training using an oral device in people with Dysphagia and Stroke, run by Umeå University at 1 site in Sweden.
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 1 inclusion and 2 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 8 May 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 Sweden. 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?
Contact Patricia Hägglund, PhD/SLP (+46907850000, patricia.hagglund@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing Function (time frame: At start compared with at end of treatment (after 3 months)). 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 NCT02960737, which also lists 1 linked publication.
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 8 May 2026.