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

March 16, 2015 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study in a tertiary teaching hospital, National Taiwan University Hospital. Patients are eligible with age ≧ 20 years old, severe OSA [apnea-hyponea index (AHI) >= 30/hr] who could not tolerate CPAP pressure >15 cmH2O, determined by manual titration (first titration) and willing to use OA.

The study designed was found out the patients with severe OSA (AHI >= 30/hr ). With first titration, the investigators excluded the severe OSA patients using CPAP (CPAP pressure < 15 cmH2O) and could tolerate CPAP. Those patients who could not tolerance CPAP high pressure setting started a three-month oral appliance trial. Then, the investigators repeated the full-channel polysomnography (PSG) with second titration on those with residual AHI ≧ 10/hr while patients were on OA. Therefore, those patients treated with combinations of OA and CPAP for three months and then repeated the PSG. The washout period in each therapy was two weeks. The total follow-up period is about 6 months after enrolled.

The investigators collected the demographic data from medical records and PSG data, including age, gender, body mass index (BMI), CPAP titration, AHI, total sleep time, oxygen desaturation, and arousal index…et al.

Our primary end point is the changes in AHI compared with combination therapy, and OA use. The secondary end points are the difference in titrated CPAP pressure, BMI, blood pressure, and daytime sleepiness compared with combination therapy and OA use.

Statistics analysis Data are presented as mean ± standard deviation (SD). Continuous variables were tested by paired Student's t test in group comparisons. Statistical significance was assumed when a null hypothesis could be rejected at p<0.05. The investigators compared the difference between combination therapy, OA, and baseline by ANOVA, repeated measure. Statistical analysis was done using the SPSS 22.0 for Windows.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. New diagnosed obstructive sleep apnea patients older than 20 years old
  2. AHI more than 30/hr with moderate to severe obstructive sleep apnea
  3. Willing to accept CPAP and OA treatment

Exclusion Criteria:

  1. nasal problems causing CPAP intolerance
  2. status post uvulopalatopharyngoplasty
  3. alcohol abuse and dependence
  4. life expectancy less than 6 months
  5. severe cardiopulmonary distress.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OA, CPAPm, combination therapy
Device: OA, CPAP, combination therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference of AHI (Apnea Hypopnea Index ) in different treatment (baseline, OA, combination therapy)
Time Frame: baseline and1, 3, 6 months later

The participants will be followed every month over out patient clinic with measures of change with AHI, sleep quality of life with different treatment (baseline, OA, combination treatment group).

The investigators will record the AHI in different treatment group with OA, CPAP or combination therapy and read if AHI decreased after combination therapy use.
baseline and1, 3, 6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Peilin Lee, PhD, Center of Sleep Disorder, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201402033RINC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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