HIV Infections, Insomnia
Conditions
Keywords
HIV, Insomnia, Cytokines, Adherence
Brief summary
This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.
Detailed description
Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population. Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.
Interventions
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Insomnia * HIV Seropositive * Stable HIV Disease
Exclusion criteria
* Other psychiatric illnesses * Unstable HIV disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response: Change in Insomnia Severity Rating Scale at 3 Months. | Baseline and 3 months | Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Piper Fatigue Scale at 3 Months | Baseline and 3 months | A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from an HIV clinic in the Department of Internal Medicine, Duke University Medical Center
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 1 sugar pill taken nightly at bedtime. | 18 |
| Temazepam 1 15 mg pill taken nightly at bedtime. | 23 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Temazepam | Total | Placebo |
|---|---|---|---|
| Age Continuous | 47.8 Years STANDARD_DEVIATION 7.9 | 48.1 Years STANDARD_DEVIATION 6.6 | 48.46 Years STANDARD_DEVIATION 5.1 |
| Insomnia Severity Index | 16.6 Scores on a scale STANDARD_DEVIATION 5.1 | 17.1 Scores on a scale STANDARD_DEVIATION 5 | 17.7 Scores on a scale STANDARD_DEVIATION 4.9 |
| Piper Fatigue Scale | 114 Scores on a scale STANDARD_DEVIATION 48 | 116 Scores on a scale STANDARD_DEVIATION 45 | 138 Scores on a scale STANDARD_DEVIATION 42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 38 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Male | 13 Participants | 23 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 18 | 4 / 23 |
| serious Total, serious adverse events | 0 / 18 | 0 / 23 |
Outcome results
Primary
Response: Change in Insomnia Severity Rating Scale at 3 Months.
Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.
Time frame: Baseline and 3 months
Population: This is the LOCF population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Response: Change in Insomnia Severity Rating Scale at 3 Months. | 0.72 units on a scale | Standard Deviation 6.1 |
| Temazepam | Response: Change in Insomnia Severity Rating Scale at 3 Months. | -4.01 units on a scale | Standard Deviation 5.3 |
Secondary
Change in Piper Fatigue Scale at 3 Months
A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.
Time frame: Baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Piper Fatigue Scale at 3 Months | 12 units on a scale | Standard Deviation 6.1 |
| Temazepam | Change in Piper Fatigue Scale at 3 Months | 17 units on a scale | Standard Deviation 5.3 |