NCT05977296

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 22, 2025

Status Verified

August 1, 2024

Enrollment Period

3.7 years

First QC Date

July 18, 2023

Last Update Submit

May 19, 2025

Conditions

DysphagiaOSACPAP

Keywords

Obstructive sleep apneaOral frailtyDysphagiaCPAP

Outcome Measures

Primary Outcomes (28)

  • 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.

    Baseline

  • 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.

    2 or 4 weeks, 3 months, 6 months

  • 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.

    3 months

  • 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.

    6 months

  • 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.

    Baseline

  • 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.

    2 or 4 weeks

  • 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.

    3 months

  • 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.

    6 months

  • 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.

    Baseline

  • 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.

    2 or 4 weeks

  • 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.

    3 months

  • 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.

    6 months

  • 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.

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

  • 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.

    2 or 4 weeks

  • 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.

    3 months, 6 months

  • 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.

    6 months

  • 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.

    Baseline

  • 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.

    2 or 4 weeks

  • 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.

    3 months

  • 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.

    6 months

  • 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

    Baseline

  • 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

    2 or 4 weeks

  • 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

    3 months

  • 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

    6 months

  • 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.

    Baseline

  • 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.

    2 or 4 weeks

  • 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.

    3 months

  • 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.

    6 months

Study Arms (2)

OSA patients

EXPERIMENTAL

The 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.

Device: CPAP

Usual group

NO INTERVENTION

In 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.

Interventions

CPAPDEVICE

To use CPAP

OSA patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan, Taiwan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Deglutition DisordersSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Yen-Chin Chen

CONTACT

+886-6-2353535yenchin2427@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Head Nurse and Clinical Assistant Professor

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 4, 2023

Study Start

April 14, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 22, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)