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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
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 20 20
Completed 19 17
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             1             3
Arm/Group Title Prazosin Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
Comparison on demographic variables
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
29.7  (6.55) 27.2  (6.25) 27.7  (5.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
3
  15.0%
4
  20.0%
7
  17.5%
Male
17
  85.0%
16
  80.0%
33
  82.5%
1.Primary Outcome
Title Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose
Hide Description The reported Z value reflect the magnitude of the state difference (Wake vs. Non-REM or Wake vs. REM) within the prazosin group pre-to-post treatment, and after using a mask to adjust for the spurious effects of the passage of time.
Time Frame Baseline and post-intervention at 8-10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9 of the 20 participants who were randomized to prazosin and 13 of the participants randomized to placebo provided scans pre- and post-treatment that were of sufficiency quality to be included in the final analyses.
Arm/Group Title Prazosin -Placebo
Hide Arm/Group Description:
Difference in relative brain glucose metabolism between states and pre-to-post treatment for participants randomized to prazosin after adjusting for non-significant changes in the placebo group.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: Z values
Pre-to-Post Treatment (Wakefulness > NREM) 3.78
Pre-to-Post Treatment (Wakefulness < NREM) 3.76
Pre-to-Post Treatment (Wakefulness > REM) 3.52
Pre-to-Post Treatment (Wakefulness < REM) 3.36
Within-state time-dependent decrease in rCMRglc 4.12
Within-state time-dependent increase in rCMRglc 3.89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prazosin -Placebo
Comments Wakefulness > Non-Rapid Eye Movement (NREM): Mean K-cluster voxels (Ke)=15,586: x,y,z= -36, -74, 0. Left Brodmann's Area (BA) 3, 6, 7, 10, 17, 19, 20,21,23, 38
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for significance: <.05
Method Full Factorial ANOVAs and Paired T-tests
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Prazosin -Placebo
Comments Wakefulness < NREM: Ke=7,013: x,y,z= 26, 22, -40. Right BA 4, 10-14, 21, 25, 32, 38, 45;
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments Threshold for significance: <.05
Method Full Factorial ANOVAs and Paired T-tests
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Prazosin -Placebo
Comments Wakefulness > (Rapid Eye Movement (REM): No cluster size, coordinates, or brain regions to report
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments Threshold for significance: <.05
Method Full Factorial ANOVAs and Paired T-tests
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Prazosin -Placebo
Comments Wakefulness < REM: No cluster size, coordinates, or brain regions to report
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments Threshold for significance: <.05
Method Full Factorial ANOVAs and Paired T-tests
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Prazosin -Placebo
Comments Within-state decrease in rCMRglc: Ke=6,150: x,y,z= -30, -30, 2. Left BA 40, insula, hippocampus, caudate, and putamen;
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Threshold for significance: <.05
Method Full Factorial ANOVAs and Paired T-tests
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Prazosin -Placebo
Comments Within-state increase in rCMRglc: Ke=7,049: x,y,z= 66, -18, 26. Right BA 1, 3, 15, 21, 22, 23, 41, 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments Threshold for significance: <.05
Method Full Factorial ANOVAs and Paired T-tests
Comments [Not Specified]
2.Secondary Outcome
Title Pittsburgh Sleep Quality Index (PSQI):
Hide Description Self-report sleep quality measure. Scores range from 0 to 21, with higher scores reflecting poorer sleep quality.
Time Frame Baseline and post-treatment at 8-10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9 of the 20 participants who were randomized to prazosin and 13 of the participants randomized to prazosin provided scans pre- and post-treatment that were of sufficiency quality to be included in the final analyses.
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 9 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
PSQI: Baseline 9.25  (2.64) 8.08  (2.72)
PSQI: Post 6.71  (4.31) 6.54  (2.57)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Prazosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Prazosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prazosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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
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