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

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Moscow State Medical University, Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change from baseline in quality of sleep questionnaire

Time frame: Baseline, 3 weeks

Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment.

Secondary outcomes

Change from baseline in attention Questionnaire

Time frame: Baseline, 3 weeks
Change from baseline in memory Questionnaire

Time frame: Baseline, 3 weeks
Percentage of patients responding "unsatisfied", "effective therapy", "very effective therapy", respectively, in the patient satisfaction assessment

Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Open-label, Post-marketing Observational Study to Evaluate the Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

Acronym: QUALISLEEP

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Dec 22, 2014
Registry last updated: Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed