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Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans (NOSSTIP)

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ClinicalTrials.gov Identifier: NCT01637584
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : April 17, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Anne Germain, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Non PTSD
PTSD
Interventions: Drug: Prazosin
Drug: Placebo

  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
Prazosin

Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.

Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.

Placebo

A placebo is a sugar pill, which will be used to compare with the results of the active medication

Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.


Participant Flow:   Overall Study
    Prazosin   Placebo
STARTED   20   20 
COMPLETED   19   17 
NOT COMPLETED   1   3 
Withdrawal by Subject                1                3 



  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.
Comparison on demographic variables

Reporting Groups
  Description
Prazosin

Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.

Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.

Placebo

A placebo is a sugar pill, which will be used to compare with the results of the active medication

Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.

Total Total of all reporting groups

Baseline Measures
   Prazosin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.7  (6.55)   27.2  (6.25)   27.7  (5.14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  15.0%      4  20.0%      7  17.5% 
Male      17  85.0%      16  80.0%      33  82.5% 


  Outcome Measures

1.  Primary:   Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose   [ Time Frame: Baseline and post-intervention at 8-10 weeks ]

2.  Secondary:   Pittsburgh Sleep Quality Index (PSQI):   [ Time Frame: Baseline and post-treatment at 8-10 weeks ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Anne Germain
Organization: UPittsburgh
phone: 4123832150
e-mail: germax@upmc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anne Germain, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01637584     History of Changes
Other Study ID Numbers: PRO08050307
First Submitted: June 15, 2012
First Posted: July 11, 2012
Results First Submitted: January 7, 2016
Results First Posted: April 17, 2017
Last Update Posted: May 23, 2017