CPAP, Dysphagia, OSA
Conditions
Keywords
Obstructive sleep apnea, Oral frailty, Dysphagia, CPAP
Brief summary
The purpose of this study is to evaluate the effects of the CPAP treatment on oral frailty and dysphagia among OSA patients.
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.
Interventions
DEVICECPAP
To use CPAP
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline_Poor occlusal force | 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. |
| Within 1-month_Poor occlusal force | 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-month_Poor occlusal force | 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. |
| 6-month_Poor occlusal force | 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. |
| Baseline_Poor masticatory function | 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. |
| Within 1-month_Poor masticatory function | 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. |
| 3-month_Poor masticatory function | 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. |
| 6-month_Poor masticatory function | 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. |
| Baseline_Poor tongue-lip motor function | 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. |
| Within 1-month_Poor tongue-lip motor function | 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. |
| 3-month_Poor tongue-lip motor function | 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. |
| 6-month_Poor tongue-lip motor function | 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. |
| Baseline_Low tongue pressure | 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. |
| Within 1-month_Low tongue pressure | 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. |
| 3-month_Low tongue pressure | 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. |
| 6-month_Low tongue pressure | 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. |
| Baseline_Low swallowing tongue pressure | 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. |
| Within 1-month_Low swallowing tongue pressure | 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. |
| 3-month_Low swallowing tongue pressure | 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. |
| 6-month_Low swallowing tongue pressure | 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. |
| Baseline_Dysphagia | 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 |
| Within 1-month_Dysphagia | 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 |
| 3-month_Dysphagia | 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 |
| 6-month_Dysphagia | 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 |
| Baseline_Oral Health status | 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. |
| Within 1-month_Oral Health status | 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. |
| 3-month_Oral Health status | 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. |
| 6-month_Oral Health status | 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. |
Countries
Taiwan
Outcome results
None listed