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Combinations of Oral Appliance and CPAP for Patients With Severe Obstructive Sleep Apnea Untolerate High-pressure CPAP

NCT02217397 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-18

No results posted yet for this study

Summary

Obstructive sleep apnea (OSA) is a situation of repetitive upper airway obstruction during sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was the standard therapy, especially those with daytime sleepiness and cardiovascular comorbidities. Although CPAP is effective in OSA treatment, the poor adherence due to high pressure was often reported. Instead, oral appliance (OA) was the alternative for those who could not tolerance CPAP or mild to moderate OSA. Oral appliance was less effective in compared with CPAP, but OA is more tolerable and acceptable in OSA patients.

Only one observation study addressed the effects of the combinations of OA and CPAP in OSA patients . The pilot study displayed combination therapy of CPAP and OA is effective in OSA patients and could decrease CPAP pressure. However, the study enrolled the patients with CPAP intolerance according to the subjective chief complaint, not the objective CPAP pressure data. In the present study, we studied the effects of combinations of CPAP and OA for patients with severe OSA who could not tolerate CPAP with high-pressure setting.

Conditions

Interventions

DEVICE

OA, CPAP, combination therapy

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Peilin Lee, PhD · Center of Sleep Disorder, National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02217397 on ClinicalTrials.gov