Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 11:15 PM
Study NCT ID:
NCT02825927
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2016-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swallowing Function, Oral Health, and Food Intake in Old Age
Sponsor:
Umeå University
Organization:
Study Overview
Official Title:
Swallowing Function, Oral Health, and Food Intake in Old Age
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOFIA
Brief Summary:
The purpose of this study is to determine whether a specific rehabilitation program with oral screen used in an elderly population with dysphagia can improve elderly's swallowing capacity.
Detailed Description:
The present study aims to investigate the effects on swallowing function of a specific rehabilitation program with oral screen in the elderly population included. The present study is a part of an on-going cross-sectional, descriptive project called SOFIA where approximately 400 elderly individuals, admitted to short-term care (from the five regions/county Dalarna, Gävleborg, Örebro, Värmland and Västerbotten in Sweden), will be included. The purpose of the overall project is to gain a broader understanding of aspects of dysphagia, eating, oral health, and quality of life and care among elderly people in short-term care facilities.
In the present study, 35 elderly individuals identified with dysphagia in the overall project (swallowing capacity \<10ml/sec) and without known dementia will be offered to participate and to undergo oral screen training for 5 weeks. The participants' status regarding swallowing, eating, quality of life and oral health will be assessed before and immediately after the intervention and 6-months post-intervention. A control group (35 people in short-term accommodation included in the overall project, identified with dysphagia but not offered the intervention) will undergo the same assessments (at start, after 5 weeks, and 6-month post-intervention) as the intervention group regarding swallowing, eating, quality of life and oral health status.
Cluster randomisation of short-term accommodation facilities will be made for those patients participating from the five regions/county to either intervention group or control group. Participants will be recruited consecutively to either the intervention- or the control group, depending on which short-term care facility they are staying at.
The investigators hypothesize that oral screen rehabilitation for elderly individuals with dysphagia and with different diagnoses treated in short-term care results in improved swallowing capacity.
In the present study, 35 elderly individuals identified with dysphagia in the overall project (swallowing capacity \<10ml/sec) and without known dementia will be offered to participate and to undergo oral screen training for 5 weeks. The participants' status regarding swallowing, eating, quality of life and oral health will be assessed before and immediately after the intervention and 6-months post-intervention. A control group (35 people in short-term accommodation included in the overall project, identified with dysphagia but not offered the intervention) will undergo the same assessments (at start, after 5 weeks, and 6-month post-intervention) as the intervention group regarding swallowing, eating, quality of life and oral health status.
Cluster randomisation of short-term accommodation facilities will be made for those patients participating from the five regions/county to either intervention group or control group. Participants will be recruited consecutively to either the intervention- or the control group, depending on which short-term care facility they are staying at.
The investigators hypothesize that oral screen rehabilitation for elderly individuals with dysphagia and with different diagnoses treated in short-term care results in improved swallowing capacity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: