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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00051363 |
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).
Condition | Intervention | Phase |
---|---|---|
Lung Diseases Sleep Apnea Syndromes Sleep |
Device: Positive Pressure Respiration Device: Sham CPAP machine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | APPLES: Apnea Positive Pressure Long-Term Efficacy Study |
Enrollment: | 1105 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Active CPAP
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Device: Positive Pressure Respiration
Nightly nasal continuous positive airway pressure (CPAP)
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2: Placebo Comparator
Sham CPAP
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Device: Sham CPAP machine
Sham CPAP machine will be used for participants in the placebo group.
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
University of Arizona AHSC | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Stanford University School of Medicine | |
Palo Alto, California, United States, 94305 | |
United States, Massachusetts | |
Brigham & Women's Hospital | |
Boston, Massachusetts, United States, 02459 | |
United States, Missouri | |
St. Luke's Hospital | |
Chesterfield, Missouri, United States, 63017 | |
United States, Washington | |
St. Mary Medical Center | |
Walla Walla, Washington, United States, 99362 |
Study Chair: | William C. Dement, MD, PhD | Stanford University |
Principal Investigator: | Clete A. Kushida, MD, PhD | Stanford University |
Responsible Party: | Stanford University School of Medicine ( Clete A. Kushida, M.D., Ph.D., Principal Investigator ) |
Study ID Numbers: | 150, U01 HL068060 |
Study First Received: | January 9, 2003 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00051363 |
Health Authority: | United States: Federal Government |
Obstructive Sleep Apnea |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Lung Diseases Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Pathologic Processes Disease Syndrome Nervous System Diseases |