A Phase 3 interventional study of Zolpidem and Zoplicone in Sleep, Sleep Disorders and Insomnia, sponsored by Brasilia University Hospital. Completed at 1 site in Brazil. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Brasilia University Hospital · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the treatment of sleep disorders in Alzheimer's disease (AD)
Sleep disorders (SD) affects 35 to 50 percent of patients with AD. These disorders often make caring for patients at home very difficult. Zolpidem and Zoplicone are prescribed drugs for sleep disorder in AD patients.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 62 is close to the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Brasilia University Hospital is the lead sponsor of 20 studies on the registry; none are open to participants now.
Compared within Sleep Initiation and Maintenance Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sleep Wake Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights
Drug: Zolpidem
Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights
Drug: Zoplicone
Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights
Drug: Placebo
Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights
Inactive or inert pill which will be used as a comparator
Nighttime Total Sleep Time
Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
Time frame: Baseline, 14 days follow-up
Daytime Total Sleep Time
Daytime Total Sleep Time (in minutes) during the 12h daytime period (8:00am-8:00pm) after 2 weeks under treatment
Time frame: Baseline, 14 days follow-up
Ratio of daytime to nighttime sleep
Daytime Total Sleep Time / Nighttime Total Sleep Time
Time frame: Baseline, 14 days follow-up
Nighttime Wake after Sleep Onset
Nighttime Wake after Sleep Onset (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
Time frame: Baseline, 14 days follow-up
Proportion of sleep time at nighttime
Proportion of sleep time (%) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
Time frame: Baseline, 14 days follow-up
Proportion of patients with gain of at least 30 minutes in Total Sleep Time
Proportion of patients with gain of at least 30 minutes in Total Sleep Time after 2 weeks under treatment
Time frame: Baseline, 14 days follow-up
Differences between sleep efficiency between the two treatments.
Analyze possible differences between sleep efficiency between the two treatments after 2 weeks under treatment
Time frame: Baseline, 14 days follow-up
Nighttime Number of Awakenings
Change in scores of nighttime number of awakenings from baseline to intervention weeks
Time frame: Baseline, 14 days follow-up
Plan to share: No
Ran from Oct 2016 to primary completion in Apr 2020, 42 months.
Of 42 phase 3 interventional studies under Sleep Initiation and Maintenance Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 28. This study's 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zolpidem
Sleep Initiation and Maintenance Disorders →
Brasilia University Hospital