William C. Dement
Apnea Positive Pressure Long-Term Efficacy Study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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).
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Device: Continuous Postitive Air Pressure (CPAP)
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can not participate as controls.Key Inclusion Criteria:
Male or female adults age 18 years or older with a diagnosis of OSAS using clinical criteria defined by the study protocol
Key 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, cardiac rhythm disturbance, 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
Pregnancy anytime during a subject's participation
Psychiatric illness, as defined by a DSM-IV diagnosis, except for depression or mild anxiety
Narcolepsy, idiopathic hypersomnolence, DSM-IV chronic insomnia, restless legs syndrome, or rapid eye movement (REM) behavior disorder
Current use of diurnal or nocturnal supplemental oxygen
Significant vision, hearing, or coordination problems
Difficulty understanding or speaking English
Currently working night or rotating shifts
Consumption of >10 caffeinated beverages per day (approximately 1,000 mg per day)
Smokers whose habit interferes with the overnight polysomnogram or with the battery of testing during the day
Consumption of >2 alcoholic beverages per day
Any illicit drug usage or marijuana usage >1/wk
Any individual in the household currently on CPAP or on CPAP in the past
A score of 26 or less on the Mini Mental State Examination (MMSE)
Additional Study Details
Official Title:
APPLES: Apnea Positive Pressure Long-Term Efficacy StudyAnticipated start date:
12/1/0003Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Effect of CPAP on neurocognitive function (measured at Month 6)
Secondary Outcomes:
- Attention and psychomotor (A/P) function
- Learning and memory (L/M) function
- Executive and frontal-lobe (E/F) function
- Sleepiness/Alertness
- Mood
- Quality of Life (all measured at Month 6)
Total Number to be Enrolled:
1516Total Number to be Enrolled at Stanford:
410More Information
Publications About this Study:
- 17561541: The Apnea Positive Pressure Long-term Efficacy Study (APPLES): rationale, design, methods, and procedures.
Secondary ID(s):
- NCT00051363
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
12/14/2007PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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