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

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

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Drug: Placebo; Drug: Songha Night ®

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Songha Night ®	Drug: Songha Night ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 1998
• Primary Completion (Actual): December 1, 1998

Study Registration Dates

• First Submitted: July 7, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 582.1