Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT00626210
First received: February 20, 2008
Last updated: December 27, 2012
Last verified: December 2012

February 20, 2008
December 27, 2012
February 2008
April 2011   (final data collection date for primary outcome measure)
Improvement of nighttime sleep quality and continuity. [ Time Frame: ~1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626210 on ClinicalTrials.gov Archive Site
Improvement of daytime alertness and quality of life. [ Time Frame: ~1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Insomnia
  • Sleep Initiation and Maintenance Disorders
  • Alzheimer Disease
Drug: modafinil
100-400 mg daily for 4 weeks
Other Name: Provigil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
October 2012
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
  • Subjective complaint of sleep disruption, unsatisfactory sleep, early morning awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made by either the potential participant or by the caregiver.

Exclusion Criteria:

  • Participation in any other clinical drug trial
  • Liver failure
  • Believed by the investigator to be unwilling or unable to follow the protocol
  • Active liver or coronary disease
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00626210
8564
No
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
VA Palo Alto Health Care System
Not Provided
Principal Investigator: Jamie M Zeitzer, PhD Stanford University/VAPAHCS
VA Palo Alto Health Care System
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP