Clinical Trials Directory

Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of Armodafinil (200 mg/Day) on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea

The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Placebo
  • drug : Armodafinil

Phase: Phase 4

Eligibility

Ages Eligible For Study:

18 Years - 60 Years

Inclusion Criteria

- Patient has a current diagnosis of OSAHS and has a complaint of excessive sleepiness despite effective nCPAP therapy. - Patient has excessive sleepiness as evidenced by a mean sleep latency of less than 8 minutes, as determined by the MSLT. - Patient has an ESS score of 10 or more at the initial screening visit. - Patient has a habitual sleep time beginning no earlier than 2100 and ending no later than 0700. - Patient is right-handed. Patients who are ambidextrous may be eligible following consultation with the medical monitor. - Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. - Patient exhibits reasonable accuracy (?80%) on the 2-back working memory task during the training session at the second screening visit.

External Links

Contact information

Primary Contact:

Chia-Yu Cardell 6507217576

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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