xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977296</url>
    </required_header>
    <id_info>
      <org_study_id>A-ER110-551</org_study_id>
      <nct_id>NCT05977296</nct_id>
    </id_info>
    <brief_title>Obstructive Sleep Apnea (OSA), Oral Frailty, Dysphagia, Continuous Positive Airway Pressure (CPAP)</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cheng-Kung University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cheng-Kung University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the effects of the CPAP treatment on oral frailty&#xD;
        and dysphagia among OSA patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research will be divided into three stages. The first stage will investigate the&#xD;
        incidence of OSA in patients over 50 years old using the National Health Insurance Research&#xD;
        Database (NHIRD). The second stage will examine the relationships among OSA, oral frailty,&#xD;
        and dysphagia through an observational case-control study with 225 OSA patients and 225&#xD;
        controls. The third stage will evaluate the effects of CPAP treatment on oral frailty and&#xD;
        dysphagia among moderate-severe OSA persons through a prospective cohort study with repeat&#xD;
        four times measurements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 14, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Baseline_Poor occlusal force</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Within 1-month_Poor occlusal force</measure>
      <time_frame>2 or 4 weeks, 3 months, 6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-month_Poor occlusal force</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6-month_Poor occlusal force</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline_Poor masticatory function</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Within 1-month_Poor masticatory function</measure>
      <time_frame>2 or 4 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-month_Poor masticatory function</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6-month_Poor masticatory function</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline_Poor tongue-lip motor function</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Within 1-month_Poor tongue-lip motor function</measure>
      <time_frame>2 or 4 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-month_Poor tongue-lip motor function</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6-month_Poor tongue-lip motor function</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline_Low tongue pressure</measure>
      <time_frame>Baseline, 2 or 4 weeks, 3 months, 6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Within 1-month_Low tongue pressure</measure>
      <time_frame>2 or 4 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-month_Low tongue pressure</measure>
      <time_frame>3 months, 6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6-month_Low tongue pressure</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline_Low swallowing tongue pressure</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Within 1-month_Low swallowing tongue pressure</measure>
      <time_frame>2 or 4 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-month_Low swallowing tongue pressure</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6-month_Low swallowing tongue pressure</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline_Dysphagia</measure>
      <time_frame>Baseline</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Within 1-month_Dysphagia</measure>
      <time_frame>2 or 4 weeks</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-month_Dysphagia</measure>
      <time_frame>3 months</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6-month_Dysphagia</measure>
      <time_frame>6 months</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Baseline_Oral Health status</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Within 1-month_Oral Health status</measure>
      <time_frame>2 or 4 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-month_Oral Health status</measure>
      <time_frame>3 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6-month_Oral Health status</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">450</enrollment>
    <condition>Dysphagia</condition>
    <condition>OSA</condition>
    <condition>CPAP</condition>
    <arm_group>
      <arm_group_label>OSA patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CPAP</intervention_name>
      <description>To use CPAP</description>
      <arm_group_label>OSA patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 50 years or older.&#xD;
  &#xD;
            -  Medically diagnosed with obstructive sleep apnea (apnea and hypopnea index, AHI, ≥ 5&#xD;
               events per hour).&#xD;
  &#xD;
            -  Clear consciousness and able to communicate in Mandarin or Taiwanese.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Central sleep apnea patients.&#xD;
  &#xD;
            -  Patients with neurological or muscular disorders (such as stroke or Parkinson's&#xD;
               disease).&#xD;
  &#xD;
            -  Patients diagnosed with oral cancer currently undergoing oral treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yen-Chin Chen</last_name>
      <phone>+886-6-2353535</phone>
      <phone_ext>2019</phone_ext>
      <email>yenchin2427@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University</name>
        <address>
          <city>Tainan</city>
          <zip>704</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>YenChin Chen</last_name>
        <phone>+886-6-2353535</phone>
        <phone_ext>2019</phone_ext>
        <email>yenchin2427@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
      <investigator_full_name>Chen, Yen-Chin</investigator_full_name>
      <investigator_title>Vice Head Nurse and Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Obstructive sleep apnea</keyword>
    <keyword>Oral frailty</keyword>
    <keyword>Dysphagia</keyword>
    <keyword>CPAP</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Deglutition Disorders</mesh_term>
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977296
  org study id: A-ER110-551
  nct id: NCT05977296
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the effects of the CPAP treatment on oral frailty
        and dysphagia among OSA patients.
  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.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Baseline_Poor occlusal force
  time frame: Baseline
  description: 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.
  measure: Within 1-month_Poor occlusal force
  time frame: 2 or 4 weeks, 3 months, 6 months
  description: 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.
  measure: 3-month_Poor occlusal force
  time frame: 3 months
  description: 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.
  measure: 6-month_Poor occlusal force
  time frame: 6 months
  description: 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.
  measure: Baseline_Poor masticatory function
  time frame: Baseline
  description: 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.
  measure: Within 1-month_Poor masticatory function
  time frame: 2 or 4 weeks
  description: 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.
  measure: 3-month_Poor masticatory function
  time frame: 3 months
  description: 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.
  measure: 6-month_Poor masticatory function
  time frame: 6 months
  description: 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.
  measure: Baseline_Poor tongue-lip motor function
  time frame: Baseline
  description: 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.
  measure: Within 1-month_Poor tongue-lip motor function
  time frame: 2 or 4 weeks
  description: 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.
  measure: 3-month_Poor tongue-lip motor function
  time frame: 3 months
  description: 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.
  measure: 6-month_Poor tongue-lip motor function
  time frame: 6 months
  description: 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.
  measure: Baseline_Low tongue pressure
  time frame: Baseline, 2 or 4 weeks, 3 months, 6 months
  description: 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.
  measure: Within 1-month_Low tongue pressure
  time frame: 2 or 4 weeks
  description: 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.
  measure: 3-month_Low tongue pressure
  time frame: 3 months, 6 months
  description: 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.
  measure: 6-month_Low tongue pressure
  time frame: 6 months
  description: 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.
  measure: Baseline_Low swallowing tongue pressure
  time frame: Baseline
  description: 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.
  measure: Within 1-month_Low swallowing tongue pressure
  time frame: 2 or 4 weeks
  description: 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.
  measure: 3-month_Low swallowing tongue pressure
  time frame: 3 months
  description: 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.
  measure: 6-month_Low swallowing tongue pressure
  time frame: 6 months
  description: 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.
  measure: Baseline_Dysphagia
  time frame: Baseline
  description: 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
  measure: Within 1-month_Dysphagia
  time frame: 2 or 4 weeks
  description: 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
  measure: 3-month_Dysphagia
  time frame: 3 months
  description: 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
  measure: 6-month_Dysphagia
  time frame: 6 months
  description: 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
  measure: Baseline_Oral Health status
  time frame: Baseline
  description: 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.
  measure: Within 1-month_Oral Health status
  time frame: 2 or 4 weeks
  description: 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.
  measure: 3-month_Oral Health status
  time frame: 3 months
  description: 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.
  measure: 6-month_Oral Health status
  time frame: 6 months
  description: 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.
  arm group label: OSA patients
  arm group type: Experimental
  description: 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.
  arm group label: Usual group
  arm group type: No Intervention
  description: 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.
  intervention type: Device
  intervention name: CPAP
  description: To use CPAP
  arm group label: OSA patients
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yen-Chin Chen
  phone: +886-6-2353535
  phone ext: 2019
  email: yenchin2427@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: National Cheng-Kung University Hospital
  investigator full name: Chen, Yen-Chin
  investigator title: Vice Head Nurse and Clinical Assistant Professor
  mesh term: Deglutition Disorders
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Frailty
  sharing ipd: No