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

Insomnia Clinical Trial

— QUALISLEEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321449
• Other study ID #: A-38-59010-001
• Status: Completed
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia

Locations

Country	Name	City	State
Russian Federation	First Moscow State Medical University	Moscow
Russian Federation	Research and Education Center of Moscow State University named after M.V. Lomonosov	Moscow
Russian Federation	State research center of preventive medicine	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in quality of sleep questionnaire	Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment.	Baseline, 3 weeks
Secondary	Change from baseline in attention Questionnaire		Baseline, 3 weeks
Secondary	Change from baseline in memory Questionnaire		Baseline, 3 weeks
Secondary	Percentage of patients responding "unsatisfied", "effective therapy", "very effective therapy", respectively, in the patient satisfaction assessment		3 weeks