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
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Insomnia
Interventions: Drug: Doxepin
Drug: Temazepam
Drug: Placebo

  Participant Flow


  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.
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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  
Number of Participants  
[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  
Piper Fatigue Scale [2]
[units: Scores on a scale]
Mean ± Standard Deviation
  138  ± 42     114  ± 48     116  ± 45  
[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.
[2] 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 ]

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


  Serious Adverse Events


  Other Adverse Events


  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
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