The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances

Phase 3

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: Songha Night ®; Drug: Placebo

• Registration Number: NCT02183714
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-05
• Primary Completion: 1998-12
• Status Verified: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-07
• Last Update Submitted: 2014-07-07
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Psychophysiologic insomnia
• Severity: mild to moderate
• Duration: subacute to chronic
• Subjects age > 18 and < 65, men or women
• Subject had to give written informed consent

Exclusion Criteria

• Regular use of psycho-active drugs
• Work in shifts
• Use of psychoactive drugs during the past 30 days
• Any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
• known hypersensitivity to any of the ingredients of the study drug
• Pregnancy, lactation, women of childbearing potential not using an established contraceptive
• Drug and alcohol abuse
• Participation in another trial within the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Songha Night ®	Songha Night ®	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in sleep quality on a 100 mm visual analogue scale (VAS)	baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment

Secondary Outcome Measures

Name	Time	Method
Feeling refreshed score (six point rating scale)	up to week 5
Ability to concentrate and perform well score (six point rating scale)	up to week 5
Night-time total sleeping time	up to week 5
Difficulty in falling asleep (five point rating scale)	up to week 5
Number of awakenings during the night	up to week 5
Physical and mental health state by short form (SF-36) questionnaire	up to week 5
Anxiety by State-Trait Anxiety Inventory	up to week 5
Frequency of adverse events	up to week 5
Global clinical impression on insomnia by short questionnaire	up to week 5