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

National Cheng-Kung University

Status: Enrolling

Conditions: Dysphagia; OSA; CPAP

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT05977296

A-ER110-551

Details and patient eligibility

About

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

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

450 participants in 2 patient groups

OSA patients

Experimental group

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.

Treatment:

Device: CPAP

Usual group

No Intervention group

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.