A Phase 2/3 interventional study of CBT-I plus placebo and CBT-I plus Melatonin 3 mg in Insomnia Disorder, sponsored by Ache Laboratorios Farmaceuticos S.A.. Status unknown at 8 sites in Brazil. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Ache Laboratorios Farmaceuticos S.A. · Phase 2/3, Interventional, and Treatment
National clinical trials, phase II/III, combined in two stages, randomized, double-blind, controlled, parallel, study of superiority, in which three hundred and seven (307) participants of both sexes, aged equal or more than 55 years will be randomly allocated to one of three treatment groups. In the first stage. The group 01 will use Melatonin 3mg plus CBT-I, the group 02 will use Melatonin 5mg plus CBT-I and the group 03 will use CBT-I plus placebo.
Based on the results of an interim analysis will be making a decision on whether to proceed with the study and, if so, on which the doses will be selected for the second stage of the study, to be better studied. The final analysis of the treatments, melatonin in the selected dose plus CBT-I versus CBT-I alone and placebo, will include participants from both stages.
The treatment of insomnia disorder can be accomplished through pharmacological and nonpharmacological approaches. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The Sleep hygiene is a psychoeducational intervention that teaches patients to prevent external or environmental factors generate adverse effects and harmful to sleep. The stimulus control technique is based on five instructions that encourages the patient to establish a proper sleep-wake rhythm and strengthens the links between the way for a quick sleep and well established. Melatonin is a hormone that participates in the regulation of the sleep-wake cycle, which is produced and secreted primarily by the pineal gland in the dark period and prepares the individual to sleep. Melatonin is involved in the induction of sleep and has proven therapeutic action in insomnia disorders, and may also play a role in the circadian timing system of mammals and serve as a marker for "biological clock".
Exclusion Criteria:
It's a tablet manufactured by Aché S.A., composed of melatonin 3mg. Melatonin 3mg tablet will be dispensed to 65 participants (first stage) of this group in a cartridge of 3 blisters with 10 tablets each, totalizing 30 tablets. If this arm is the best set for the second stage, more 56 participants will be randomly allocated in this group.The participant shall administer 01 tablet orally every 24 hours one hour before bedtime. The duration of treatment may be 21(±2) days. CBT-I is a non-pharmacological effective treatment for insomnia disorder. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The CBT-I guidelines are standardized in protocol.
Behavioral: CBT-I plus placebo · Drug: CBT-I plus Melatonin 3 mg
It's a tablet manufactured by Aché S.A., composed of melatonin 5mg. Melatonin 5mg tablet will be dispensed to 65 participants (first stage) of this group in a cartridge of 3 blisters with 10 tablets each, totalizing 30 tablets. If this arm is the best set for the second stage, more 56 participants will be randomly allocated in this group.The participant shall administer 01 tablet orally every 24 hours one hour before bedtime. The duration of treatment may be 21(±2) days. CBT-I is a non-pharmacological effective treatment for insomnia disorder. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The CBT-I guidelines are standardized in protocol.
Behavioral: CBT-I plus placebo · Drug: CBT-I plus Melatonin 5 mg
It's a tablet manufactured by Aché S.A,. composed of placebo. The participants shall administer the placebo tablets to enable the double-blind study. Placebo will be dispensed to 65 (first stage) and 56 (second stage) participants of this group and shall administer 01 tablet orally every 24 hours one hour before bedtime for 21(±2) days. Sleep hygiene is a psychoeducational intervention that teaches patients to prevent external or environmental factors generate adverse effects and harmful to sleep. The stimulus control technique is based on five instructions that encourages the patient to establish a proper sleep-wake rhythm and strengthens the links between the way for a quick and well consolidated sleep. The CBT-I guidelines are standardized in clinical protocol.
Behavioral: CBT-I plus placebo
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus placebo (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days)
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 3 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.
Also known as: Melatonin
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 5 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.
Also known as: Melatonin
Change of Sleep Latency after 21 (±2) days of the treatment.
Absolute change in sleep latency (in minutes) at the end of treatment compared to baseline. Sleep latency will be assessed by polysomnography.
Time frame: 21 (±2) days
Quality of Sleep - Pittsburgh Sleep Quality Index
Absolute change the overall score PSQI-BR, at the end of treatment from baseline
Time frame: 21 (±2) days
Wellness Day - Well-Being Index-5 (WHO-5)
Absolute change the overall score of the WHO-5 level, in the range of 0 to 100 points, at the end of treatment from baseline.
Time frame: 21 (±2) days
Severity of Insomnia - Insomnia Severity Index
Absolute change the overall score of the Insomnia Severity Index at the end of treatment from baseline
Time frame: 21 (±2) days
Total Sleep Time - Polysomnography
Evaluate the total sleep time by polysomnography at the end of treatment from baseline
Time frame: 21 (±2) days
Sleep Architecture - the length and proportion of N1(non-rapid eyes movement) stages, N2, N3 and REM
Proportion of participants with sleep architecture classified as normal or abnormal, assessed by polysomnography at the end of treatment from baseline.
Time frame: 21 (±2) days
Sleep Efficiency - Polysomnography
Sleep efficiency variation assessed by polysomnography at the end of treatment from baseline
Time frame: 21 (±2) days
The Latency of Persistent Sleep - Polysomnography
Latency of persistent sleep variation assessed by polysomnography at the end of treatment from baseline
Time frame: 21 (±2) days
Latency of REM (rapid eyes movement) Sleep - Polysomnography
Latency of REM sleep variation assessed by polysomnography at the end of treatment from baseline
Time frame: 21 (±2) days
Satisfaction of the participants with the treatment.
Proportion of participants in each level of satisfaction category Likert 5 point (1. totally dissatisfied, 2. dissatisfied, 3. neither satisfied nor dissatisfied, 4. satisfied, 5. completely satisfied) evaluated comparing the groups at the end of treatment
Time frame: 21 (±2) days
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Ache Laboratorios Farmaceuticos S.A.