Trial Outcomes & Findings for Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans (NCT NCT01637584)

NCT ID: NCT01637584

Last Updated: 2017-05-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline and post-intervention at 8-10 weeks
• Results posted on: 2017-05-23

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans

Baseline characteristics by cohort

Measure	Prazosin n=20 Participants 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 n=20 Participants 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 n=40 Participants Total of all reporting groups
Age, Continuous	29.7 years STANDARD_DEVIATION 6.55 • n=5 Participants	27.2 years STANDARD_DEVIATION 6.25 • n=7 Participants	27.7 years STANDARD_DEVIATION 5.14 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and post-intervention at 8-10 weeks

Population: 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.

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.

Outcome measures

Measure	Prazosin -Placebo n=22 Participants 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.	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.
Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose Pre-to-Post Treatment (Wakefulness > NREM)	3.78 Z values	—
Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose Pre-to-Post Treatment (Wakefulness < NREM)	3.76 Z values	—
Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose Pre-to-Post Treatment (Wakefulness > REM)	3.52 Z values	—
Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose Pre-to-Post Treatment (Wakefulness < REM)	3.36 Z values	—
Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose Within-state time-dependent decrease in rCMRglc	4.12 Z values	—
Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose Within-state time-dependent increase in rCMRglc	3.89 Z values	—

SECONDARY outcome

Timeframe: Baseline and post-treatment at 8-10 weeks

Population: 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.

Self-report sleep quality measure. Scores range from 0 to 21, with higher scores reflecting poorer sleep quality.

Outcome measures

Measure	Prazosin -Placebo n=9 Participants 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.	Placebo n=13 Participants 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.
Pittsburgh Sleep Quality Index (PSQI): PSQI: Baseline	9.25 units on a scale Standard Deviation 2.64	8.08 units on a scale Standard Deviation 2.72
Pittsburgh Sleep Quality Index (PSQI): PSQI: Post	6.71 units on a scale Standard Deviation 4.31	6.54 units on a scale Standard Deviation 2.57

Adverse Events

Prazosin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anne Germain

UPittsburgh

Phone: 4123832150

Email: germax@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place