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Home > "A" Clinical Trials Conditions > APPLES: Apnea Positive Pressure Long-Term Efficacy Study  APPLES: Apnea Positive Pressure Long-Term Efficacy Study
APPLES: Apnea Positive Pressure Long-Term Efficacy Study
For Condition: Sleep Apnea Syndromes,Sleep,Lung Diseases
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine the effectiveness of nasal continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome.
Details: BACKGROUND: Nasal continuous positive airway pressure (CPAP) therapy is in widespread use as the primary treatment for the obstructive sleep apnea syndrome (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 1050 subjects (525 per treatment group) will be enrolled from the patient populations at five sites (Stanford University; University of Arizona; Harvard Medical School; St. Luke's Hospital, Missouri; St. Mary's Hospital, Washington).
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Male or female adults age 18 years or older with a diagnosis of obstructive sleep apnea syndrome (OSAS) using clinical criteria defined by the study protocol. Study participation may require seven or more laboratory visits over six months. Exclusion Criteria Prior treatment for OSAS with continuous positive airway pressure or surgery. Potential sleep apnea complications that may affect the health or safety of the participant including low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, congestive heart failure, history of angina, coronary artery disease, myocardial infarction or stroke, and chronic neurological disorders affecting neurocognitive abilities or daily function. The use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants or other medications likely to affect neurocognitive function and/or alertness. Respiratory disease requiring medications (unless on stable medications for 2 months) Cancer, unless in remission for greater than one year and not taking exclusionary medications Self-reported renal failure
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamDement, , Stanford University
St. Mary Medical Center *Recruiting*
Walla Walla, Washington, 99362
United States
Recruiting Kevin Hurburt 509-522-5845
Brigham & Women's Hospital *Recruiting*
Boston, Massachusetts, 02459
United States
Recruiting Denise Clarke 617-527-2227 x146
Stanford *Recruiting*
Palo Alto, California, 94305
United States
Recruiting Eileen Leary 650-724-9639
St. Luke's Hospital *Recruiting*
Chesterfield, Missouri, 63017
United States
Recruiting Paula Schweitzer 314-205-6325
University of Arizona AHSC *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Chuck Wynstra 520-626-5001
Additional Information:
Study ID Numbers: 150;
Study Start Date: September 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051363
Other Lung Diseases Studies:
1. APPLES: Apnea Positive Pressure Long-Term Efficacy Study
2. Validation and Exploration of Sleep and Mood Predictors
Related Studies:
Other Lung Diseases Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
APPLES: Apnea Positive Pressure Long-Term Efficacy Study
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