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Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

This study has been terminated.
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System Identifier:
First received: February 20, 2008
Last updated: October 28, 2014
Last verified: October 2014
Results First Received: June 12, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Insomnia
Sleep Initiation and Maintenance Disorders
Alzheimer Disease
Intervention: Drug: modafinil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Modafinil daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week

Participant Flow:   Overall Study

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Modafinil Open label study in which all participants get modafinil

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   0 
>=65 years   2 
[Units: Participants]
Female   0 
Male   2 
Region of Enrollment 
[Units: Participants]
United States   2 

  Outcome Measures

1.  Primary:   Nocturnal Sleep Length at 1 Month   [ Time Frame: 1 month ]

2.  Secondary:   Improvement of Daytime Alertness and Quality of Life.   [ Time Frame: ~1 month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed

  More Information