Status:
COMPLETED
Effectiveness of BBT-I and Zopiclone for Chronic Insomnia
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Insomnia Chronic
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Background: Importance of chronic insomnia (CI) problem is determined by its high prevalence rate, comorbidity and resistance to the treatment. Although cognitive behavior treatment of insomnia (CBT-I...
Detailed Description
The study had a crossover design implying that every patient underwent two different treatment courses in random sequence: hypnotic or structured educational program (BBT-I) delivered in two sessions....
Eligibility Criteria
Inclusion
- meeting the criteria for chronic insomnia according ICSD-3 willingness to take part in the study and signed informed consent form
Exclusion
- unability to stop taking medications that have a proven impact on sleep at least one week before and during the study;
- history of alcohol or drug abuse;
- major depressive disorder or other severe mental disorder identified by a clinical assessment and medical history;
- dementia;
- pregnancy or lactation;
- shift or night work;
- medical problems that would be a direct cause of sleep complaints: moderate/severe sleep apnea, defined as an apnea-hypopnea index of ≥15 events per hour, periodic limb movement disorder defined as a periodic leg movement index ≥15 events per hour or restless legs syndrome;
- other serious chronic conditions or exacerbation of chronic disorder preventing further participation.
Key Trial Info
Start Date :
April 7 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2017
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03339583
Start Date
April 7 2015
End Date
March 14 2017
Last Update
September 16 2019
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