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This study aims to evaluate how effective trazodone is in treating insomnia in adults aged 65 years and older. The main question it aims to answer is :
- Is trazodone more effective than a placebo in reducing the severity of insomnia symptoms in older adults?
Participants will :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover Trazodone then Placebo arm | Experimental | Participants will receive 25 to 50 mg of trazodone once daily at bedtime for 28 days. After a 14-day washout period, participants will receive a placebo for another 28 days. |
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| Crossover Placebo then Trazodone arm | Experimental | Participants will receive a placebo once daily at bedtime for 28 days. After a 14-day washout period, participants will receive 25 to 50 mg of trazodone for another 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone 25 mg | Drug | Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Insomnia severity index | The ISI is a self-assessment questionnaire that evaluates the nature, severity, and impact of insomnia. The typical recall period is the past month. The dimensions assessed are: the severity of falling asleep, maintaining sleep, and waking up too early in the morning; sleep dissatisfaction; the interference of sleep difficulties with daytime functioning; the visibility of sleep problems to others; and the distress caused by sleep difficulties. A 5-point Likert scale is used to evaluate each item. The total score is interpreted as follows: no insomnia 0-7; subclinical insomnia 8-14; moderate insomnia 15-21; and severe insomnia 22-28. It is increasingly used as a measure of treatment response in clinical research. Data confirm its reliability and the validity of the measurements obtained in the older adult population. | At baseline or at day 1, at day 36 and at day 77. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia daytime symptoms and Impacts Questionnaire | The IDSIQ is a questionnaire covering 14 different items that specifically measures the impact of insomnia on various aspects of daytime functioning. The questions are grouped into three areas, each representing the main daytime symptoms and impacts of insomnia on drowsiness (four items), alertness/cognition (six items), and mood (four items). Each item is rated on an 11-point numerical scale (from 0 to 10), with lower scores indicating better daytime functioning. It has been found to be sensitive to changes in patients experiencing daytime effects. It is quick to administer, easy to complete, and has reliable reproducibility (test-retest). It can be used in clinical trials to assess changes and the effectiveness of a treatment on daytime functioning and for the recording of new drugs for insomnia. Regulatory authorities now require that the effectiveness of clinical trials for medical products against insomnia be measured not only by treating physicians but also by the p |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Nguyen, B. Pharm, M.Sc. | Contact | 514-890-8000 | 36163 | patrick.nguyen.chum@ssss.gouv.qc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
There is no need since it is a single center study.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
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| At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Subjective Sleep onset latency | Subjective time duration, in minutes, between the time the participant attempts to fall asleep (e.g., lights off, lying in bed) and the time they perceive they have fallen asleep. | At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Subjective wake after sleep onset | The perceived total duration, in minutes, of all periods of wakefulness occurring after initial sleep onset and before final awakening | At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Subjective Total sleep time | The perceived total duration, in minutes, of actual sleep obtained during the night, excluding periods of wakefulness. | At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Subjective sleep efficiency | The perceived percentage of time spent asleep while in bed, calculated as the ratio of subjective total sleep time (sTST) to time in bed (TIB), multiplied by 100 | At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Objective sleep onset latency | The estimated duration, in minutes, between the time the participant attempts to fall asleep (e.g., lights out or bedtime) and the onset of the first sustained period of sleep, as detected by actigraphy | At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Objective Wake After Sleep Onset | The estimated total duration, in minutes, of wakefulness occurring after the initial sleep onset and before final awakening, as detected by actigraphy | At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Objective Total Sleep Time | The estimated total duration, in minutes, of actual sleep obtained during the sleep period, as detected by actigraphy, excluding all periods of wakefulness | At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Objective Sleep Efficiency | The estimated percentage of time spent asleep while in bed, calculated as the ratio of objective total sleep time (oTST) to objective time in bed (oTIB), multiplied by 100 as measured by actigraphy. | At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment |
| Adverse events | Incidence of at least one adverse event. Incidence of severe adverse events. Proportion of participants who discontinued due to adverse events. | At Day 36 and day 77 |
| D001523 |
| Mental Disorders |
| D011725 |
| Pyridines |