AzTrials
AzTrials

DysphagiaNCT05977296

Obstructive Sleep Apnea (OSA), Oral Frailty, Dysphagia, Continuous Positive Airway Pressure (CPAP)

A study testing CPAP in people with Dysphagia and OSA, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effects of the CPAP treatment on oral frailty and dysphagia among OSA patients. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Dysphagia, OSA, CPAP
What is being tested?
CPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteTaiwan
Study dates
14 Apr 2022to 31 Dec 2025
Phase
Interventional
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 50 years or older.
  • Medically diagnosed with obstructive sleep apnea (apnea and hypopnea index, AHI, ≥ 5 events per hour).
  • Clear consciousness and able to communicate in Mandarin or Taiwanese.

Who cannot join

  • Central sleep apnea patients.
  • Patients with neurological or muscular disorders (such as stroke or Parkinson's disease).
  • Patients diagnosed with oral cancer currently undergoing oral treatment.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

    Tainan, Taiwan, 704

Other trials in Taiwan

About this study

Official title: The Effects of Continuous Positive Airway Pressure (CPAP) on Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea(OSA): A Prospective Cohort Study Design

The purpose of this study is to evaluate the effects of the CPAP treatment on oral frailty and dysphagia among OSA patients.

Read the detailed description

The research will be divided into three stages. The first stage will investigate the incidence of OSA in patients over 50 years old using the National Health Insurance Research Database (NHIRD). The second stage will examine the relationships among OSA, oral frailty, and dysphagia through an observational case-control study with 225 OSA patients and 225 controls. The third stage will evaluate the effects of CPAP treatment on oral frailty and dysphagia among moderate-severe OSA persons through a prospective cohort study with repeat four times measurements.

Conditions
Dysphagia, OSA, CPAP
Being tested
CPAP
Keywords
Obstructive sleep apnea, Oral frailty, Dysphagia, CPAP
Medical subject headings
Deglutition Disorders, Sleep Apnea, Obstructive

What participants receive

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

  • CPAPDevice

    To use CPAP

Study groups in NCT05977296
Study groupRoleWhat they receive
OSA patientsExperimentalThe experimental group in this study consisted of individuals who were assigned to the CPAP (Continuous Positive Airway Pressure) intervention. Participants in the experimental group were instructed to wear a CPAP device during their sleep.
Receives: Device: CPAP
Usual groupNo interventionIn the control group, participants received standard or routine nursing care without any specific interventions(CPAP) or modifications. The standard nursing care provided to the participants followed established protocols and guidelines commonly practiced in general healthcare settings.

What is being measured

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

  1. Baseline_Poor occlusal force

    The investigators will determine the total count of natural teeth and fixed dentures among the participants. If the combined number of natural teeth and fixed dentures is below 20, it indicates a reduced occlusal force.

    Measured: Baseline

  2. Within 1-month_Poor occlusal force

    The investigators will determine the total count of natural teeth and fixed dentures among the participants. If the combined number of natural teeth and fixed dentures is below 20, it indicates a reduced occlusal force.

    Measured: 2 or 4 weeks, 3 months, 6 months

  3. 3-month_Poor occlusal force

    The investigators will determine the total count of natural teeth and fixed dentures among the participants. If the combined number of natural teeth and fixed dentures is below 20, it indicates a reduced occlusal force.

    Measured: 3 months

  4. 6-month_Poor occlusal force

    The investigators will determine the total count of natural teeth and fixed dentures among the participants. If the combined number of natural teeth and fixed dentures is below 20, it indicates a reduced occlusal force.

    Measured: 6 months

  5. Baseline_Poor masticatory function

    The investigators will utilize a 14-food group questionnaire to evaluate the masticatory function of the participants. If participants select 'difficult to eat' as their response for four items, it indicates a decline in the masticatory function.

    Measured: Baseline

  6. Within 1-month_Poor masticatory function

    The investigators will utilize a 14-food group questionnaire to evaluate the masticatory function of the participants. If participants select 'difficult to eat' as their response for four items, it indicates a decline in the masticatory function.

    Measured: 2 or 4 weeks

  7. 3-month_Poor masticatory function

    The investigators will utilize a 14-food group questionnaire to evaluate the masticatory function of the participants. If participants select 'difficult to eat' as their response for four items, it indicates a decline in the masticatory function.

    Measured: 3 months

  8. 6-month_Poor masticatory function

    The investigators will utilize a 14-food group questionnaire to evaluate the masticatory function of the participants. If participants select 'difficult to eat' as their response for four items, it indicates a decline in the masticatory function.

    Measured: 6 months

  9. Baseline_Poor tongue-lip motor function

    The investigators will assess the oral-diadochokinesis of the participants. Each participant will be instructed to repeat the syllables /pa/, /ta/, and /ka/ for a duration of 5 seconds. If the number of /pa/ syllables produced per second is below 6, it indicates a decline in tongue-lip motor function.

    Measured: Baseline

  10. Within 1-month_Poor tongue-lip motor function

    The investigators will assess the oral-diadochokinesis of the participants. Each participant will be instructed to repeat the syllables /pa/, /ta/, and /ka/ for a duration of 5 seconds. If the number of /pa/ syllables produced per second is below 6, it indicates a decline in tongue-lip motor function.

    Measured: 2 or 4 weeks

  11. 3-month_Poor tongue-lip motor function

    The investigators will assess the oral-diadochokinesis of the participants. Each participant will be instructed to repeat the syllables /pa/, /ta/, and /ka/ for a duration of 5 seconds. If the number of /pa/ syllables produced per second is below 6, it indicates a decline in tongue-lip motor function.

    Measured: 3 months

  12. 6-month_Poor tongue-lip motor function

    The investigators will assess the oral-diadochokinesis of the participants. Each participant will be instructed to repeat the syllables /pa/, /ta/, and /ka/ for a duration of 5 seconds. If the number of /pa/ syllables produced per second is below 6, it indicates a decline in tongue-lip motor function.

    Measured: 6 months

  13. Baseline_Low tongue pressure

    The investigators will employ the YBERMEDIC Tongue Depressor, a tongue pressure measuring instrument, to assess the maximum tongue pressure. Participants will be instructed to press a balloon attached to their tongue against the anterior palate for several seconds, repeating this process three times. If the maximum tongue pressure is below 30 kPa, it indicates a decline in tongue pressure.

    Measured: Baseline, 2 or 4 weeks, 3 months, 6 months

  14. Within 1-month_Low tongue pressure

    The investigators will employ the YBERMEDIC Tongue Depressor, a tongue pressure measuring instrument, to assess the maximum tongue pressure. Participants will be instructed to press a balloon attached to their tongue against the anterior palate for several seconds, repeating this process three times. If the maximum tongue pressure is below 30 kPa, it indicates a decline in tongue pressure.

    Measured: 2 or 4 weeks

  15. 3-month_Low tongue pressure

    The investigators will employ the YBERMEDIC Tongue Depressor, a tongue pressure measuring instrument, to assess the maximum tongue pressure. Participants will be instructed to press a balloon attached to their tongue against the anterior palate for several seconds, repeating this process three times. If the maximum tongue pressure is below 30 kPa, it indicates a decline in tongue pressure.

    Measured: 3 months, 6 months

  16. 6-month_Low tongue pressure

    The investigators will employ the YBERMEDIC Tongue Depressor, a tongue pressure measuring instrument, to assess the maximum tongue pressure. Participants will be instructed to press a balloon attached to their tongue against the anterior palate for several seconds, repeating this process three times. If the maximum tongue pressure is below 30 kPa, it indicates a decline in tongue pressure.

    Measured: 6 months

  17. Baseline_Low swallowing tongue pressure

    The investigators will employ the YBERMEDIC Tongue Depressor, a tongue pressure measuring instrument, to assess the maximum swallowing tongue pressure. Participants will be instructed to swallow their saliva, repeating this process three times. If the maximum tongue pressure is below 15.46 kPa, it indicates a decline in swallowing tongue pressure.

    Measured: Baseline

  18. Within 1-month_Low swallowing tongue pressure

    The investigators will employ the YBERMEDIC Tongue Depressor, a tongue pressure measuring instrument, to assess the maximum swallowing tongue pressure. Participants will be instructed to swallow their saliva, repeating this process three times. If the maximum tongue pressure is below 15.46 kPa, it indicates a decline in swallowing tongue pressure.

    Measured: 2 or 4 weeks

  19. 3-month_Low swallowing tongue pressure

    The investigators will employ the YBERMEDIC Tongue Depressor, a tongue pressure measuring instrument, to assess the maximum swallowing tongue pressure. Participants will be instructed to swallow their saliva, repeating this process three times. If the maximum tongue pressure is below 15.46 kPa, it indicates a decline in swallowing tongue pressure.

    Measured: 3 months

  20. 6-month_Low swallowing tongue pressure

    The investigators will employ the YBERMEDIC Tongue Depressor, a tongue pressure measuring instrument, to assess the maximum swallowing tongue pressure. Participants will be instructed to swallow their saliva, repeating this process three times. If the maximum tongue pressure is below 15.46 kPa, it indicates a decline in swallowing tongue pressure.

    Measured: 6 months

  21. Baseline_Dysphagia

    The investigators will use the Eating Assessment Tool (EAT-10) to evaluate participants' swallowing difficulties. The EAT-10 is a straightforward assessment consisting of 10 questions, each assigned a score ranging from 0 (none) to 4 (severe). If the EAT-10 score is 3 or higher, it indicates that participants may experience challenges in swallowing efficiently and safely

    Measured: Baseline

  22. Within 1-month_Dysphagia

    The investigators will use the Eating Assessment Tool (EAT-10) to evaluate participants' swallowing difficulties. The EAT-10 is a straightforward assessment consisting of 10 questions, each assigned a score ranging from 0 (none) to 4 (severe). If the EAT-10 score is 3 or higher, it indicates that participants may experience challenges in swallowing efficiently and safely

    Measured: 2 or 4 weeks

  23. 3-month_Dysphagia

    The investigators will use the Eating Assessment Tool (EAT-10) to evaluate participants' swallowing difficulties. The EAT-10 is a straightforward assessment consisting of 10 questions, each assigned a score ranging from 0 (none) to 4 (severe). If the EAT-10 score is 3 or higher, it indicates that participants may experience challenges in swallowing efficiently and safely

    Measured: 3 months

  24. 6-month_Dysphagia

    The investigators will use the Eating Assessment Tool (EAT-10) to evaluate participants' swallowing difficulties. The EAT-10 is a straightforward assessment consisting of 10 questions, each assigned a score ranging from 0 (none) to 4 (severe). If the EAT-10 score is 3 or higher, it indicates that participants may experience challenges in swallowing efficiently and safely

    Measured: 6 months

  25. Baseline_Oral Health status

    The Oral Health Assessment Tool (OHAT) is a clinical assessment tool designed for frail older individuals to self-evaluate their oral health status. It encompasses eight categories of oral health, including lips, tongue, gums and oral tissue, natural teeth, dentures, oral cleanliness, saliva secretion, and dental pain. Each category is assessed on a scale of 0 (healthy), 1 (changes), or 2 (unhealthy). The overall scores range from 0 to 16, with a higher OHAT score indicating poorer oral health.

    Measured: Baseline

  26. Within 1-month_Oral Health status

    The Oral Health Assessment Tool (OHAT) is a clinical assessment tool designed for frail older individuals to self-evaluate their oral health status. It encompasses eight categories of oral health, including lips, tongue, gums and oral tissue, natural teeth, dentures, oral cleanliness, saliva secretion, and dental pain. Each category is assessed on a scale of 0 (healthy), 1 (changes), or 2 (unhealthy). The overall scores range from 0 to 16, with a higher OHAT score indicating poorer oral health.

    Measured: 2 or 4 weeks

  27. 3-month_Oral Health status

    The Oral Health Assessment Tool (OHAT) is a clinical assessment tool designed for frail older individuals to self-evaluate their oral health status. It encompasses eight categories of oral health, including lips, tongue, gums and oral tissue, natural teeth, dentures, oral cleanliness, saliva secretion, and dental pain. Each category is assessed on a scale of 0 (healthy), 1 (changes), or 2 (unhealthy). The overall scores range from 0 to 16, with a higher OHAT score indicating poorer oral health.

    Measured: 3 months

  28. 6-month_Oral Health status

    The Oral Health Assessment Tool (OHAT) is a clinical assessment tool designed for frail older individuals to self-evaluate their oral health status. It encompasses eight categories of oral health, including lips, tongue, gums and oral tissue, natural teeth, dentures, oral cleanliness, saliva secretion, and dental pain. Each category is assessed on a scale of 0 (healthy), 1 (changes), or 2 (unhealthy). The overall scores range from 0 to 16, with a higher OHAT score indicating poorer oral health.

    Measured: 6 months

Timeline

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

  1. First posted4 Aug 2023
  2. Study start14 Apr 2022
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05977296
Sponsor's protocol ID
A-ER110-551
Status last verified
May 2026
First submitted
18 Jul 2023
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen YC, Lin CY, Chen YC, Lam LT, Lindayani L, Yen YF, Chen YH. Domain-Specific Oral Hypofunction in Older Adults With Obstructive Sleep Apnoea: A Case-Control Study. J Oral Rehabil. 2026 Oct 26. doi: 10.1111/joor.70350. Online ahead of print.

    PubMed 42933905

Questions about this trial

What is this clinical trial studying?

A study testing CPAP in people with Dysphagia and OSA, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 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 Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline_Poor occlusal force (time frame: Baseline). The study lists 28 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 NCT05977296, 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 22 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in