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. The revised proposed 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 this proposed study is the effect of 6 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; U of Arizona; Harvard; St. Luke's Hospital, MO; St. Mary's Hospital, WA). This study will advance our knowledge of the major, most debilitating, clinically relevant OSAS-associated conditions, and, by scientifically establishing the effectiveness of CPAP therapy, should greatly improve access for the countless victims now denied treatment.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL068060-01A1
Application #
6521648
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Twery, Michael
Project Start
2002-09-30
Project End
2007-07-31
Budget Start
2002-09-30
Budget End
2003-09-12
Support Year
1
Fiscal Year
2002
Total Cost
$3,230,933
Indirect Cost
Name
Stanford University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
800771545
City
Stanford
State
CA
Country
United States
Zip Code
94305
Budhiraja, Rohit; Kushida, Clete A; Nichols, Deborah A et al. (2017) Predictors of sleepiness in obstructive sleep apnoea at baseline and after 6?months of continuous positive airway pressure therapy. Eur Respir J 50:
Batool-Anwar, Salma; Baldwin, Carol M; Fass, Shira et al. (2017) ROLE OF SPOUSAL INVOLVEMENT IN CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) ADHERENCE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA (OSA). Southwest J Pulm Crit Care 14:213-227
Holmes, Tyson H; Kushida, Clete A (2017) Adherence to continuous positive airway pressure improves attention/psychomotor function and sleepiness: a bias-reduction method with further assessment of APPLES. Sleep Med 37:130-134
Budhiraja, Rohit; Kushida, Clete A; Nichols, Deborah A et al. (2016) Impact of Randomization, Clinic Visits, and Medical and Psychiatric Cormorbidities on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea. J Clin Sleep Med 12:333-41
Holmes, Tyson H; Zulman, Donna M; Kushida, Clete A (2016) Adjustment for Variable Adherence Under Hierarchical Structure: Instrumental Variable Modeling Through Compound Residual Inclusion. Med Care :
Batool-Anwar, Salma; Goodwin, James L; Kushida, Clete A et al. (2016) Impact of continuous positive airway pressure (CPAP) on quality of life in patients with obstructive sleep apnea (OSA). J Sleep Res 25:731-738
Batool-Anwar, Salma; Goodwin, James L; Drescher, Amy A et al. (2014) Impact of CPAP on activity patterns and diet in patients with obstructive sleep apnea (OSA). J Clin Sleep Med 10:465-72
Quan, Stuart F; Budhiraja, Rohit; Batool-Anwar, Salma et al. (2014) Lack of Impact of Mild Obstructive Sleep Apnea on Sleepiness, Mood and Quality of Life. Southwest J Pulm Crit Care 9:44-56
Huynh, Nelly T; Prilipko, Olga; Kushida, Clete A et al. (2014) Volumetric Brain Morphometry Changes in Patients with Obstructive Sleep Apnea Syndrome: Effects of CPAP Treatment and Literature Review. Front Neurol 5:58
Quan, Stuart F; Budhiraja, Rohit; Clarke, Denise P et al. (2013) Impact of treatment with continuous positive airway pressure (CPAP) on weight in obstructive sleep apnea. J Clin Sleep Med 9:989-93

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