Clinical trial NCT05977296: Obstructive Sleep Apnea (OSA), Oral Frailty, Dysphagia, Continuous Positive Airway Pressure (CPAP)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
OSA
CPAP
Keywords: Obstructive sleep apnea
Oral frailty
Dysphagia
CPAP
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 450
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline_Poor occlusal force
timeFrame: Baseline
measure: Within 1-month_Poor occlusal force
timeFrame: 2 or 4 weeks, 3 months, 6 months
measure: 3-month_Poor occlusal force
timeFrame: 3 months
measure: 6-month_Poor occlusal force
timeFrame: 6 months
measure: Baseline_Poor masticatory function
timeFrame: Baseline
measure: Within 1-month_Poor masticatory function
timeFrame: 2 or 4 weeks
measure: 3-month_Poor masticatory function
timeFrame: 3 months
measure: 6-month_Poor masticatory function
timeFrame: 6 months
measure: Baseline_Poor tongue-lip motor function
timeFrame: Baseline
measure: Within 1-month_Poor tongue-lip motor function
timeFrame: 2 or 4 weeks
measure: 3-month_Poor tongue-lip motor function
timeFrame: 3 months
measure: 6-month_Poor tongue-lip motor function
timeFrame: 6 months
measure: Baseline_Low tongue pressure
timeFrame: Baseline, 2 or 4 weeks, 3 months, 6 months
measure: Within 1-month_Low tongue pressure
timeFrame: 2 or 4 weeks
measure: 3-month_Low tongue pressure
timeFrame: 3 months, 6 months
measure: 6-month_Low tongue pressure
timeFrame: 6 months
measure: Baseline_Low swallowing tongue pressure
timeFrame: Baseline
measure: Within 1-month_Low swallowing tongue pressure
timeFrame: 2 or 4 weeks
measure: 3-month_Low swallowing tongue pressure
timeFrame: 3 months
measure: 6-month_Low swallowing tongue pressure
timeFrame: 6 months
measure: Baseline_Dysphagia
timeFrame: Baseline
measure: Within 1-month_Dysphagia
timeFrame: 2 or 4 weeks
measure: 3-month_Dysphagia
timeFrame: 3 months
measure: 6-month_Dysphagia
timeFrame: 6 months
measure: Baseline_Oral Health status
timeFrame: Baseline
measure: Within 1-month_Oral Health status
timeFrame: 2 or 4 weeks
measure: 3-month_Oral Health status
timeFrame: 3 months
measure: 6-month_Oral Health status
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Study officials:
References: