The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

Completed

• Conditions: Insomnia

• Registration Number: NCT02321449
• Lead Sponsor: Ipsen

Brief Summary

To evaluate the effectiveness of treatment with Circadin based on sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after the treatment

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male and female patients aged ≥ 55 years suffering from non-organic insomnia according to International Classification of Diseases (ICD-10)
• Patients with sleep disorders manifested as poor sleep quality associated with impaired daytime functioning with or without one or more of the following criteria: difficulty falling asleep, frequent night awakenings, early morning awakenings
• Patients able to follow the study protocol
• Patients who have signed the Informed Consent prior to initiation of any observation-related procedures
• Patients with a global score of ≤17 inclusively on the modified Questionnaire Scoring Subjective Characteristics of Sleep
• Patients who have just been identified to receive treatment with Circadin
• Patients without previous treatment with Circadin

Exclusion Criteria

• Hypersensitivity to any components of Circadin
• Congenital galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency
• Pregnancy and lactation
• Alcohol or drug addiction
• Severe somatic and neurological conditions, exacerbations thereof, including autoimmune diseases or renal/hepatic insufficiency
• Intake of psychoactive medicines within the last 30 days before observational study entry
• Presence of clinically significant anxiety and depression as assessed by the Hospital Anxiety and Depression Scale
• Presence of pain that might be the cause for insomnia. Subjects suffering from breathing related sleep disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in quality of sleep questionnaire	Baseline, 3 weeks	Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients responding "unsatisfied", "effective therapy", "very effective therapy", respectively, in the patient satisfaction assessment	3 weeks
Change from baseline in attention Questionnaire	Baseline, 3 weeks
Change from baseline in memory Questionnaire	Baseline, 3 weeks

Trial Locations

Locations (3)

State research center of preventive medicine; 🇷🇺 Moscow, Russian Federation

Research and Education Center of Moscow State University named after M.V. Lomonosov; 🇷🇺 Moscow, Russian Federation

First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation