Pilot study - Evaluation and correlation of different measurement methods for tablet swallowability and palatability in test persons aged = 12 years for the development of a standardised procedure

Not Applicable

• Conditions: o specific disease required for study participation, as placebo is taken for investigation of swallowing.

• Registration Number: DRKS00030313
• Lead Sponsor: Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-28
• Study Completion: 2023-03-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Age
Five different age groups or groups of test persons are included

- 12 - 17 years
- 18 - 30 years
- 31 - 65 years healthy tablet inexperienced (= 1 tablet per week)
- 31 - 65 years multimorbid tablet-experienced (daily intake of = 3 tablets)
- 66 years and older

2. Gender
Half female and half male

3. Health
All participants will be screened using a standardised adult examination form to ensure that their ability to swallow is not impaired and that they are actually able to swallow.

4. Compliance
Subjects and, if applicable, guardians understand and are willing and able to comply with the screening procedures and restrictions.

5. Consent
The subject(s) and/or legal guardian(s) are able to understand the study procedures, obligations, risks and benefits of participation in this study and have provided written informed consent. In the adolescent group, the legal guardians have also given their informed consent.

Exclusion Criteria

1. Diseases
Diseases that may involve a diagnosable impairment of swallowing solids or solid oral dosage forms.
a) CNS disease (e.g. dementia, Parkinson's disease)
b) acute illness (e.g. sepsis, respiratory distress, gastroenteritis, respiratory infection)
c) Dysphagia / Presbyphagia

2. Intolerance
Lactose intolerance

3. Chronic or acute drug intake
Any drug that can cause nausea, fatigue, dry mouth or paralysis as a side effect.

4. Interventions
Invasive therapeutic interventions have been performed on the subjects prior to the study or are planned after the study.

5. Food
Subjects have eaten food at least 1 hour before the study and experience nausea. The intake of fluids is permitted.

6. Pacemaker
Subjects wearing a pacemaker are excluded from the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to investigate the discriminatory ability of the three different methods for assessing the swallowability and palatability of solid oral forms. For this purpose, standard tablets, characterised by shape and size, are used in relevant populations = 12 years. <br>The method includes the definition of the specific measurement parameters as well as the creation of the algorithms for the data evaluation of the measured values of electromyography and bioimpedance (RehaIngest®) as well as the definition of the assessment criteria for the observation of swallowability and palatability and suitability of self-assessment using the gender-specific 5-point Likert Scale. <br>Another primary goal is the correlation of measurement data of the different methods for the conceptual development of a combined method for assessing the acceptability of oral dosage forms with high validity and differentiability.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives of the study include the applicability and suitability of the methods for different age populations and populations with daily tablet-taking experience.<br>Other secondary objectives include general findings on the influence of tablet shape (oblong, round), size and age, gender and experience of use on swallowability.