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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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Insomnia
Sleep Initiation and Maintenance Disorders
Alzheimer Disease
Intervention: Drug: modafinil

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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
    Modafinil
STARTED   2 
COMPLETED   2 
NOT COMPLETED   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Modafinil Open label study in which all participants get modafinil

Baseline Measures
   Modafinil 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      2 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      2 100.0% 
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

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jamie Zeitzer
Organization: VAPAHCS
phone: 6504935000 ext 62410
e-mail: jzeitzer@stanford.edu


Publications:

Responsible Party: Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT00626210     History of Changes
Other Study ID Numbers: 8564
First Submitted: February 20, 2008
First Posted: February 29, 2008
Results First Submitted: June 12, 2014
Results First Posted: October 30, 2014
Last Update Posted: January 29, 2018