| City: |
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Denver |
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State:
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CO |
| Zip Code: |
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80206 |
| Conditions: |
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Sleep Apnea, Obstructive - Continuous Positive Airway Pressure |
| Purpose: |
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Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops
breathing or experiences shallow breathing for short periods of time during sleep. The most
common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine,
but many people have trouble adhering to the treatment schedule. This study will evaluate
the effectiveness of two behavioral therapy programs used in combination with CPAP for
improving treatment adherence in people with OSA.
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| Study summary: |
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OSA is a common sleep disorder that is characterized by a brief collapse and blockage of the
upper airway during sleep. This blockage prevents air from flowing properly into the lungs
and causes pauses in breathing. Symptoms include loud snoring, choking or gasping during
sleep, and abnormal daytime sleepiness. If left untreated, OSA can lead to heart disease,
high blood pressure, and stroke. The most common treatment for OSA is CPAP therapy, in which
a mask is worn over the nose during sleep and pressurized air flows through the mask to keep
the throat open. Unfortunately, CPAP treatment adherence is often poor. Previous research
studies showed that people receiving motivational enhancement therapy (MET) or educational
therapy (ED) adhered better to CPAP treatment than did people not receiving MET or ED
therapy. However, even for people who received MET or ED, adherence usually diminished after
12 months. It appears that patterns of treatment adherence are often set early and people
who maintain adherence within the first week of treatment have a greater chance of
maintaining long-term adherence. Using enhanced, more intense versions of MET and ED that
are delivered when CPAP therapy begins, this study will evaluate the effectiveness of MET
and ED at improving CPAP treatment adherence in people with OSA.
This study will enroll people with OSA. Participants will be randomly assigned to a 12-week
MET group, a 12-week ED group, or a standard clinical care group, with all treatments
beginning at the time participants start CPAP therapy. All participants will attend a
baseline study visit to undergo weight and blood pressure measurements; assessments of
cognitive functioning, mood, daytime sleepiness, functional outcomes, and attitudes toward
therapy; and an optional blood collection. At baseline and Week 1, participants in the MET
and ED groups will take part in two 45-minute, face-to-face counseling sessions. During
these sessions, participants in the MET group will receive motivational counseling from
study staff, and participants in the ED group will receive educational information about OSA
from study staff. At Months 1 and 3, participants will receive two phone calls from study
staff. The MET group will receive motivational counseling during these calls, with a focus
on building self-efficacy and providing personalized feedback on health and adherence
patterns. The ED group will receive educational information and feedback on problem-solving
and adherence during the calls. Throughout the study, all participants will have their CPAP
adherence electronically monitored on a daily basis. Participants who fail to meet the
minimum standard of CPAP adherence will receive up to four additional phone calls during the
study. At Months 3, 6, and 12, all participants will attend study visits for repeat baseline
measurements. |
| Criteria: |
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Inclusion Criteria:
- OSA confirmed by polysomnography (PSG)
- CPAP is the prescribed form of treatment for OSA
- Judged by sleep physician to respond to CPAP
Exclusion Criteria:
- Apnea/hypoxia index (AHI) less than 15 and no daytime functional symptoms or
associated cardiovascular disease
- Diagnosis of another sleep disorder that causes arousals from sleep
- Past treatment for OSA
- Current substance abuse problem
- Diagnosis of a serious medical condition that would interfere with involvement in the
study
- History of a major psychiatric disorder, other than depression
- Change in antidepressant medication in the 3 months before study entry |
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| Study is available at: |
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National Jewish Medical and Research Center
Denver, CO 80206
United States
Primary Contact:
Mark S. Aloia, PhD
Email: aloiam@njc.org
Phone: 303-270-2386
Secondary Contact:
Mark S. Aloia, PhD
Email: aloiam@njc.org
Phone: 303-270-2386 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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