Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)

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.

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

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.

The perceived total duration, in minutes, of all periods of wakefulness occurring after initial sleep onset and before final awakening

The perceived total duration, in minutes, of actual sleep obtained during the night, excluding periods of wakefulness.

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

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

The estimated total duration, in minutes, of wakefulness occurring after the initial sleep onset and before final awakening, as detected by actigraphy

The estimated total duration, in minutes, of actual sleep obtained during the sleep period, as detected by actigraphy, excluding all periods of wakefulness

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.

Incidence of at least one adverse event. Incidence of severe adverse events. Proportion of participants who discontinued due to adverse events.