To determine the effectiveness of nasal continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome.

Condition	Treatment or Intervention
Lung Diseases Sleep Apnea Syndromes Sleep	Device: Positive Pressure Respiration

Further Study 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).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Arizona
      University of Arizona AHSC, Tucson,  Arizona,  85724,  United States; Recruiting
California
      Stanford, Palo Alto,  California,  94305,  United States; Recruiting
Massachusetts
      Brigham & Women's Hospital, Boston,  Massachusetts,  02459,  United States; Recruiting
Missouri
      St. Luke's Hospital, Chesterfield,  Missouri,  63017,  United States; Recruiting
Washington
      St. Mary Medical Center, Walla Walla,  Washington,  99362,  United States; Recruiting

Study chairs or principal investigators

William Dement,  Stanford University   

Study ID Numbers:  150
Record last reviewed:  December 2004
Last Updated:  December 13, 2004
Record first received:  January 9, 2003
ClinicalTrials.gov Identifier:  NCT00051363
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08