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

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183714
• Other study ID #: 582.1
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2014
• Last updated: July 7, 2014
• Start date: May 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. primary completion date: December 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Songha Night ®

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Feeling refreshed score (six point rating scale)		up to week 5	No
Secondary	Ability to concentrate and perform well score (six point rating scale)		up to week 5	No
Secondary	Night-time total sleeping time		up to week 5	No
Secondary	Difficulty in falling asleep (five point rating scale)		up to week 5	No
Secondary	Number of awakenings during the night		up to week 5	No
Secondary	Physical and mental health state by short form (SF-36) questionnaire		up to week 5	No
Secondary	Anxiety by State-Trait Anxiety Inventory		up to week 5	No
Secondary	Frequency of adverse events		up to week 5	No
Secondary	Global clinical impression on insomnia by short questionnaire		up to week 5	No

External Links

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