View Clinical Trial (Medical Research Study)
Phase I Double-blind Randomized Controlled Trial: Sociocultural and Cognitive Perception Intervention to Promote Positive Airway Pressure Adherence
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Sleep Apnea, Obstructive - Patient Compliance |
| Purpose: |
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The purpose of this study is to examine the feasibility of a tailored (i.e., individualized)
intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in
adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.
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| Study Summary: |
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Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal
health and functional outcomes. Intervention studies to promote CPAP adherence have shown
relatively small effects in selected samples and were costly. The overall objective of this
research is to examine the effect, feasibility, and acceptability of a tailored intervention
on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central
hypothesis is that critically timed tailored interventions that focus on sociocultural
aspects and cognitive perceptions of the individual experience with OSA diagnosis and
treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial
will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to
the tailored intervention or usual (standard) care and examine specific feasibility and
participant acceptability outcomes in order to design and conduct a subsequent larger
randomized controlled trial testing the overall efficacy of the tailored intervention.
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| Criteria: |
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Inclusion Criteria:
- males and females >/= 18 years of age
- newly diagnosed with apnea/hypopnea index >/= 10 events/hr
- CPAP naive
- able to read and speak English
Exclusion Criteria:
- previous diagnosis and/or treatment of OSA
- major new psychiatric diagnosis within 6 months of study enrollment
- require supplemental oxygen or bilevel positive airway pressure on CPAP titration
polysomnogram
- diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb
movements >/= 10 events/hr with arousal, central sleep apnea with >/= 5 central
events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy
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| NCT ID: |
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NCT01454830 |
| Primary Contact: |
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Principal Investigator
Amy M Sawyer, PhD
The Pennsylvania State University
Amy M Sawyer, PhD
Phone: 8148631020
Email: ams24@psu.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Hershey, Pennsylvania 17033
United States
Amy M Sawyer, PhD
Phone: 717-531-8520
Email: ams24@psu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
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