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Completed

NCT Number: NCT05977296

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

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

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Key information

Conditions

Dysphagia Apnea CPAP Deglutition Disorders Digestive System Diseases Dyssomnias Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases OSA Otorhinolaryngologic Diseases Pharyngeal Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tainan, Taiwan, 704

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CPAP

Device

To use CPAP

Primary outcomes

  1. Baseline_Poor occlusal force

    Time frame: Baseline

    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. Within 1-month_Poor occlusal force

    Time frame: 2 or 4 weeks, 3 months, 6 months

    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. 3-month_Poor occlusal force

    Time frame: 3 months

    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.

  4. 6-month_Poor occlusal force

    Time frame: 6 months

    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.

  5. Baseline_Poor masticatory function

    Time frame: Baseline

    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. Within 1-month_Poor masticatory function

    Time frame: 2 or 4 weeks

    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.

  7. 3-month_Poor masticatory function

    Time frame: 3 months

    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.

  8. 6-month_Poor masticatory function

    Time frame: 6 months

    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.

  9. Baseline_Poor tongue-lip motor function

    Time frame: Baseline

    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.

  10. Within 1-month_Poor tongue-lip motor function

    Time frame: 2 or 4 weeks

    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.

  11. 3-month_Poor tongue-lip motor function

    Time frame: 3 months

    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.

  12. 6-month_Poor tongue-lip motor function

    Time frame: 6 months

    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.

  13. Baseline_Low tongue pressure

    Time frame: Baseline, 2 or 4 weeks, 3 months, 6 months

    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.

  14. Within 1-month_Low tongue pressure

    Time frame: 2 or 4 weeks

    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.

  15. 3-month_Low tongue pressure

    Time frame: 3 months, 6 months

    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.

  16. 6-month_Low tongue pressure

    Time frame: 6 months

    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.

  17. Baseline_Low swallowing tongue pressure

    Time frame: Baseline

    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.

  18. Within 1-month_Low swallowing tongue pressure

    Time frame: 2 or 4 weeks

    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.

  19. 3-month_Low swallowing tongue pressure

    Time frame: 3 months

    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.

  20. 6-month_Low swallowing tongue pressure

    Time frame: 6 months

    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.

  21. Baseline_Dysphagia

    Time frame: Baseline

    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

  22. Within 1-month_Dysphagia

    Time frame: 2 or 4 weeks

    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

  23. 3-month_Dysphagia

    Time frame: 3 months

    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

  24. 6-month_Dysphagia

    Time frame: 6 months

    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

  25. Baseline_Oral Health status

    Time frame: Baseline

    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.

  26. Within 1-month_Oral Health status

    Time frame: 2 or 4 weeks

    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.

  27. 3-month_Oral Health status

    Time frame: 3 months

    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.

  28. 6-month_Oral Health status

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
May 22, 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.

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