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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02217397
Recruitment Status : Unknown
Verified August 2014 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2014
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: OA, CPAP, combination therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combinations of Oral Appliance and CPAP for Patients With Severe Obstructive Sleep Apnea Untolerate High-pressure CPAP
Study Start Date : August 2014
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: OA, CPAPm, combination therapy Device: OA, CPAP, combination therapy

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02217397

Contact: Yi-Chun Lai, MD +886-2-23562755

Sponsors and Collaborators
National Taiwan University Hospital
Study Director: Peilin Lee, PhD Center of Sleep Disorder, National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital, Seep cencer, National Taiwan University Hospital Identifier: NCT02217397     History of Changes
Other Study ID Numbers: 201402033RINC
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: August 2014

Keywords provided by National Taiwan University Hospital:
Apnea-hyponea Index, CPAP, Obstructive Sleep Apnea, Oral Appliance

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases