NCT00051363

Apnea Positive Pressure Long-Term Efficacy Study

APPLES: Apnea Positive Pressure Long-Term Efficacy Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,105 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Lung Diseases
• Sleep Apnea Syndromes
• Sleep

Interventions

Type	Name	Description
DEVICE	Active CPAP	Nightly nasal continuous positive airway pressure (CPAP)
DEVICE	Sham CPAP	Sham CPAP machine will be used for participants in the placebo group.

Timeline

• Start date: 2002-09-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2003-01-13
• Last updated: 2018-11-28
• Results posted: 2016-11-30

Locations

5 sites across 1 country: United States