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; 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

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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
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 ]

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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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Frequency Threshold

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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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