Clinical trial NCT02321449: The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over
Official title: Open-label, Post-marketing Observational Study to Evaluate the Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female patients aged ≥ 55 years suffering from primary (non-organic) insomnia characterized by poor quality of sleep

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in quality of sleep questionnaire
timeFrame: Baseline, 3 weeks
Secondary outcomes:
measure: Change from baseline in attention Questionnaire
timeFrame: Baseline, 3 weeks
measure: Change from baseline in memory Questionnaire
timeFrame: Baseline, 3 weeks
measure: Percentage of patients responding "unsatisfied", "effective therapy", "very effective therapy", respectively, in the patient satisfaction assessment
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State research center of preventive medicine
city: Moscow
country: Russian Federation
facility: Research and Education Center of Moscow State University named after M.V. Lomonosov
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: