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Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

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ClinicalTrials.gov Identifier: NCT00626210
Recruitment Status : Terminated
First Posted : February 29, 2008
Results First Posted : October 30, 2014
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

Tracking Information
First Submitted Date  ICMJE February 20, 2008
First Posted Date  ICMJE February 29, 2008
Results First Submitted Date  ICMJE June 12, 2014
Results First Posted Date  ICMJE October 30, 2014
Last Update Posted Date January 29, 2018
Study Start Date  ICMJE February 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
Nocturnal Sleep Length at 1 Month [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
Improvement of nighttime sleep quality and continuity. [ Time Frame: ~1 month ]
Change History Complete list of historical versions of study NCT00626210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
Improvement of Daytime Alertness and Quality of Life. [ Time Frame: ~1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Official Title  ICMJE Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Sleep Initiation and Maintenance Disorders
  • Alzheimer Disease
Intervention  ICMJE Drug: modafinil
100-400 mg daily for 4 weeks
Other Name: Provigil
Study Arms  ICMJE Experimental: Modafinil
Intervention: Drug: modafinil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 27, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2008)
10
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00626210
Other Study ID Numbers  ICMJE 8564
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
Study Sponsor  ICMJE VA Palo Alto Health Care System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jamie M Zeitzer, PhD Stanford University/VAPAHCS
PRS Account VA Palo Alto Health Care System
Verification Date January 2018

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