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The Treatment of Insomnia in Patients With HIV Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00465972
First received: April 25, 2007
Last updated: July 26, 2013
Last verified: May 2013
History of Changes
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Insomnia
Interventions: Drug: Doxepin
Drug: Temazepam
Drug: Placebo

  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
Subjects were recruited from an HIV clinic in the Department of Internal Medicine, Duke University Medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

We initially planned to have 3 arms: placebo, temazepam, and doxepin. However, based on the rate of recruitment, we limited the study to 2 arms: placebo and temazepam.

Screening was carried out which included medical, and psychiatric, and sleep assessments.

Reporting Groups
  Description
Placebo One sugar pill taken orally at bedtime for duration of the participant's involvement.
Temazepam One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement.

Participant Flow:   Overall Study
    Placebo   Temazepam
STARTED   20   24 
COMPLETED   18   23 
NOT COMPLETED   2   1 
Withdrawal by Subject                2                1 



  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.
No text entered.

Reporting Groups
  Description
Placebo 1 sugar pill taken nightly at bedtime.
Temazepam 1 15 mg pill taken nightly at bedtime.
Total Total of all reporting groups

Baseline Measures
   Placebo   Temazepam   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 18   23   41 
Age 
[Units: Years]
Mean (Standard Deviation) 		 48.46  (5.1)   47.8  (7.9)   48.1  (6.6) 
Gender 
[Units: Participants]
 		     
Female   8   10   18 
Male   10   13   23 
Race (NIH/OMB) 
[Units: Participants]
 		     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   16   22   38 
White   2   1   3 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Insomnia Severity Index [1] 
[Units: Scores on a scale]
Mean (Standard Deviation) 		 17.7  (4.9)   16.6  (5.1)   17.1  (5.0) 
[1] Measures the severity of insomnia on 7 items, with a rating of 0 (low severity) to 4 (high severity). Total range for the index is 0-28; with 28 being the most severe.
Piper Fatigue Scale [1] 
[Units: Scores on a scale]
Mean (Standard Deviation) 		 138  (42)   114  (48)   116  (45) 
[1] A 22 item survey measuring level of fatigue. Subjects answer each item on a scale of 1 - 10, with 1 being low fatigue, and 10 being severe fatigue. Total range of overall score is 22-220, with 220 being severe fatigue.


  Outcome Measures
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1.  Primary:   Response: Change in Insomnia Severity Rating Scale at 3 Months.   [ Time Frame: Baseline and 3 months ]
  Show Outcome Measure 1

2.  Secondary:   Change in Piper Fatigue Scale at 3 Months   [ Time Frame: Baseline and 3 months ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Placebo 1 sugar pill taken nightly at bedtime.
Temazepam 1 15 mg pill taken orally, nightly, at bedtime.

Other Adverse Events
    Placebo   Temazepam
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   2/18 (11.11%)   4/23 (17.39%) 
Nervous system disorders     
dry mouth *     
# participants affected / at risk   1/18 (5.56%)   3/23 (13.04%) 
# events   1   3 
sedation *     
# participants affected / at risk   1/18 (5.56%)   1/23 (4.35%) 
# events   1   1 
* Events were collected by non-systematic assessment



  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
No text entered.


  More Information
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