Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06599021

Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention

Participants included in SCAPIS2 (Swedish Cardio Pulmonary bioimage study) are screened regarding swallowing difficulty using a timed water swallow test. Participants who show signs of swallowing difficulty (dysphagia) are included in the present study, which encompasses s flexible endoscopic evaluation of swallowing function (FEES). Participants showing a moderate-severe dysphagia are randomized into one of three intervention groups: muscle strengthening training, skill-based swallowing training and a control group who will receive compensatory treatment. The study is expected to improve diagnostics and treatment of swallowing difficulties in an ageing population.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dysphagia Ageing Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Intervention Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 43362, Sweden

Location status: Recruiting

Location contact

Lisa Tuomi

CONTACT

Lisa Tuomi, PhD

CONTACT

[email protected]

+46 (0)313421000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in SCAPIS2
  • Swallowing dysfunction according to timed water swallow test or
  • Swallowing dysfunction according to self-report

Exclusion criteria

  • Severely impaired intellectual abilities.
  • Inability to consent to inclusion in the study.
  • Inability to answer written questionnaires in Swedish

Inclusion of non-dysphagia control cohort: No signs of aspiration, slow swallowing (<10 ml/sec) or self-rated difficulties with eating and swallowing in sub-study SCAPIS2

Treatment and study plan

Muscular strengthening training

Behavioral

6 weeks daily muscular strengthening training.

Skill-based training

Behavioral

15 sessions skill based swallowing training lead by a speech and language pathologist during 3 weeks.

Primary outcomes

  1. Penetration-aspiration score (PAS)

    Time frame: Baseline to post-intervention (6 weeks)

    Ranges from 1-8 where 8 indicates worst possible aspiration score. Swallowing safety measured from Flexible Endoscopic Examination of Swallowing (FEES).

Secondary outcomes

  1. Dysphagia related symtoms

    Time frame: Up to 12 months post-intervention

    Patient reported outcome measurement (PROM) with Swallowing quality of life (Swal-QOL). Measures QOL depending of swallowing difficulty. Consists of 44 items divided into 10 domains and a symtom frequency scale. Scores on each domain is transformed into scores ranging from 0-100, where 100 indicates best possible swallowing QOL. The Swedish version has been fond valid and reliable.

  2. Tongue strength

    Time frame: Up to 12 months post-intervention

    Anterior and posterior tongue strength during swallowing and maximal effort is measured with the Iowa Oral Performance Instrument (IOPI)

  3. Body composition

    Time frame: Up to 12 months post-intervention

    Body composition will be measured using Bioelectric impedance analysis (BIA). Provides measures of fat-free mass and fat.

  4. Cost of intervention

    Time frame: Up to 12 months post-intervention

    Will be provided through hospital records regarding number of hospital visits and in-hospital treatment during 1 year from start of intervention.

  5. Self-perceived swallowing function

    Time frame: Up to 12 months post-intervention

    Measured with the Swedish Eating assessment tool (ÄT-10). 10 items with scores ranging from 0 to 40, higher scores indicates worse function. Scores above 3 points are considered to identify the prevalence of a swallowing dysfunction.

  6. EQ5D quality of life questionnaire

    Time frame: Up to 12 months post-intervention

    Measured with the EQ5D 5 L. Each domain is rated on a scale from 1-5 where a higher number indicates lower QOL.

  7. RAND-36 Quality of Life questionnaire

    Time frame: Up to 12 months post-intervention

    Measured with the RAND-36. Scores range between 0-100, where 100 indicates best possible outcome.

  8. Assessment of swallowing efficiency

    Time frame: Up to 12 months post-intervention

    Measurement of swallowing efficiency will be performed with the validated scale such as Yale oropharyngeal residue scale where scores range between 1-5 (none-severe)

  9. Assessment of secretion

    Time frame: Up to 12 months post-intervention

    Measurement of swallowing function will be performed with assessment of secretion using a validated eight-point scale assesses secretion severity under the subcategories of location, amount, and response. Assessment is performed in a blinded manner.

  10. Assessment of swallowing initiation

    Time frame: Up to 12 months post-intervention

    Initiation of swallowing will be assessed in a blinded manner, where initiation will be categorized referring to where te bolus reaches befor swallowing is initiated.

  11. Assessment of overall swallowing function from the FEES

    Time frame: Up to 12 months post-intervention

    Measurement of swallowing function will be performed with the Swedish tool DIGEST-FEES (Dynamic Imaging Grade of Swallowing Toxicity; FEES = flexible endoscopic evaluation of swallowing). This be utilized to describe the severity of safety, efficiency, and pharyngeal stage overall swallowing impairment on FEES. The tool will be validated for the participant group through comparisons with the other measures of swallowing function. The scale ranges from 0 (normal) to 4=life threatening

Sponsors and collaborators

Lead sponsor

Lisa Tuomi

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.