Sleep Clinical Trial
Official title:
APPLES: Apnea Positive Pressure Long-Term Efficacy Study
The purpose of this study is to determine the effectiveness of nasal continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome (OSAS).
BACKGROUND:
Nasal CPAP therapy is in widespread use as the primary treatment for OSAS, a sleep-related
breathing disorder affecting more than 15 million Americans. The therapeutic effectiveness of
CPAP in providing significant, stable, and long-term neurocognitive or other functional
benefits to patients with OSAS has not been systematically investigated.
DESIGN NARRATIVE:
The study is a randomized, blinded, sham-controlled, multi-center trial of CPAP therapy. The
principal aims of the study are: 1) to assess the long-term effectiveness of CPAP therapy on
neurocognitive function, mood, sleepiness, and quality of life by administering tests of
these indices to subjects randomly assigned to active or sham CPAP; 2) to identify specific
neurocognitive deficits associated with OSAS in a large, heterogeneous subject population; 3)
to determine which deficits in neurocognitive function in OSAS subjects are reversible and
most sensitive to the effects of CPAP; 4) to develop a composite multivariate outcome measure
from the results of this study that can be used to assess the clinical effectiveness of CPAP
in improving neurocognitive function, mood, sleepiness, and quality of life; and 5) to use
functional magnetic resonance imaging to compare cortical activation before and after CPAP
therapy, and to assess whether this change is associated with improvement in specific
neurocognitive task performance. The primary endpoint of the study is the effect of six
months of CPAP treatment on neurocognitive function. A total of 1100 subjects (550 per
treatment group) will be enrolled from the patient populations at five sites (Stanford
University; University of Arizona; Brigham and Women's Hospital; Massachusetts; St. Luke's
Hospital, Missouri; St. Mary Medical Center, Washington).
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