Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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 :
* Take 25 to 50 mg of trazodone or a matching placebo before bed for 28 days. After a 2-week break, they will then take the other medication for another 28 days. * Visit the clinic three times for checkup and test * Complete a sleep diary and wear an actimeter during the night.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 65 or older in an outpatient setting
Insomnia according to the criteria of the ICSD-3R
Disqualifiers
Contraindication to trazodone (hypersensitivity)
Presence of a ventricular cardiac arrhythmia (e.g., torsades de pointes)
Recent myocardial infarction (< 6 months)
Substances that may alter sleep (hypnotics or any other medication intended to induce sleep, such as mirtazapine or quetiapine, corticosteroids, melatonin, psychostimulant drugs)
Trial design
Design model
Crossover
Treatments tested in this trial
Trazodone 25 mg
DrugTrazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Crossover Trazodone then Placebo armExperimental treatment 1 intervention
Group B: Crossover Placebo then Trazodone armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline or at day 1, at day 36 and at day 77.Secondary outcomes
1
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
Time frame
At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment2
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.
Time frame
At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment3
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
Time frame
At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment4
Subjective Total sleep time
The perceived total duration, in minutes, of actual sleep obtained during the night, excluding periods of wakefulness.
Time frame
At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov