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The Treatment of Insomnia in Patients With HIV Disease

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00465972

First Posted: April 27, 2007

Last Update Posted: July 30, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Duke University

Results First Submitted: December 12, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (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.

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.
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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

Overall Participants Analyzed
[Units: Participants]

Age
[Units: Years]
Mean (Standard Deviation)

48.46 (5.1)

47.8 (7.9)

48.1 (6.6)

Gender
[Units: Participants]

Female

Male

Race (NIH/OMB)
[Units: Participants]

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

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 ]

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2. Secondary:

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

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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
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More Information

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