Sleep Initiation and Maintenance Disorders
Conditions
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.
Interventions
DRUGSongha Night ®
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Feeling refreshed score (six point rating scale) | 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 |
| Physical and mental health state by short form (SF-36) questionnaire | up to week 5 |
Outcome results
None listed