Trial Search Results

Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance

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 currently not accepting patients for this trial.

Lead Sponsor:


Stanford Investigator(s):


  • Drug: Armodafinil
  • Drug: Placebo


Phase 4


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.

Exclusion Criteria:

The Patient:

   - The patient is a current smoker or has a prior history of smoking (defined as ≥1
   pack-year) within 2 years prior to the screening visit.

   - consumes caffeine including coffee, tea and/or other caffeine-containing beverages or
   food averaging more than 400 mg of caffeine per day (approximately equivalent to 4 or
   more cups of coffee).

   - has NART-predicted verbal IQ and QIDS-SR16 scores within protocol-specific
   exclusionary ranges.

   - has a clinically significant, uncontrolled medical or psychiatric conditions (treated
   or untreated).

   - has a confirmed or probable diagnosis of a current sleep disorder other than OSAHS.

   - has used any excluded prescription drugs or procedures for prohibited and allowed
   drugs within the excluded timeframe.

   - has a history of alcohol, narcotic, or any other drug abuse.

   - has a positive UDS, without medical explanation, at the screening visit.

   - has a clinically significant deviation from normal in the physical examination.

   - is a pregnant or lactating woman. Any woman becoming pregnant during the study will be
   withdrawn from the study.

   - has a past or present seizure disorder, head trauma that is clinically significant, or
   past neurosurgery.

   - has used an investigational drug within 1 month before the screening visit.

   - has any disorder that may interfere with drug absorption, distribution, metabolism, or
   excretion (including gastrointestinal surgery).

   - has a known hypersensitivity to armodafinil or modafinil, or any other component of
   the study drug tablets.

   - has a history of any clinically significant cutaneous drug reaction, or a history of
   clinically significant hypersensitivity reaction, including multiple allergies or drug

   - has known human immunodeficiency virus (HIV).

   - has clinical laboratory test value(s) outside the range(s) specified in the Protocol,
   or presents a clinically significant laboratory abnormality without prior written
   approval by the medical monitor.

   - has worked the night shift within 28 days of the baseline visit, or will work the
   night shift during the double-blind segment of the study.

   - anticipates any travel across more than 3 time zones at any time during the study.

   - needs to use any of the excluded medications identified in this protocol.

   - is unable to complete neuroimaging studies, performance tasks, self-rating scales, and
   all other study assessments.

   - has a contraindication to fMRI scanning, (such as an implanted
   pacemaker/defibrillator, aneurysm clips, drug infusion device or metallic foreign

   - is suspected to be unable to tolerate fMRI scanning (eg, claustrophobic) and/or the
   testing paradigm.

   - has physical or other characteristics that suggest imaging data will be unobtainable
   or degraded.

Ages Eligible for Study

18 Years - 60 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Chia-Yu Cardell
Not Recruiting