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

NCT ID: NCT05977296

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dysphagia OSA CPAP

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OSA patients

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.

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

To use CPAP

Usual group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP

To use CPAP

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen, Yen-Chin

Vice Head Nurse and Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan City, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yen-Chin Chen

Role: CONTACT

+886-6-2353535 ext. 2019

Facility Contacts

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YenChin Chen

Role: primary

+886-6-2353535 ext. 2019

Other Identifiers

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A-ER110-551

Identifier Type: -

Identifier Source: org_study_id

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