Evaluating CPAP effects on oral health in sleep apnea patients
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
This study is testing how using a CPAP machine for sleep apnea affects oral health and swallowing in older adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan, Taiwan) |
| Trial ID | NCT05977296 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of Continuous Positive Airway Pressure (CPAP) treatment on oral frailty and dysphagia in patients diagnosed with obstructive sleep apnea (OSA) aged 50 and older. The research is structured in three stages: first, it will analyze the incidence of OSA in older adults using a national health database; second, it will explore the connections between OSA, oral frailty, and dysphagia through a case-control study involving 450 participants; and third, it will evaluate the effects of CPAP on these conditions through a prospective cohort study with multiple measurements over time.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 and older who have been medically diagnosed with obstructive sleep apnea.
Not a fit: Patients with central sleep apnea, neurological or muscular disorders, or those currently undergoing treatment for oral cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for OSA patients by addressing oral health issues related to their condition.
How similar studies have performed: While the specific combination of CPAP treatment with oral frailty and dysphagia is less explored, related studies have shown promising results in improving health outcomes for OSA patients with CPAP.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tainan, Taiwan
- National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University — Tainan, Taiwan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yen-Chin Chen
- Email: yenchin2427@gmail.com
- Phone: +886-6-2353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.