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

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ClinicalTrials.gov Identifier: NCT02183714
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: Songha Night ® Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances
Study Start Date : May 1998
Actual Primary Completion Date : December 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
Experimental: Songha Night ® Drug: Songha Night ®
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Change in sleep quality on a 100 mm visual analogue scale (VAS) [ Time Frame: baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment ]

Secondary Outcome Measures :
  1. Feeling refreshed score (six point rating scale) [ Time Frame: up to week 5 ]
  2. Ability to concentrate and perform well score (six point rating scale) [ Time Frame: up to week 5 ]
  3. Night-time total sleeping time [ Time Frame: up to week 5 ]
  4. Difficulty in falling asleep (five point rating scale) [ Time Frame: up to week 5 ]
  5. Number of awakenings during the night [ Time Frame: up to week 5 ]
  6. Physical and mental health state by short form (SF-36) questionnaire [ Time Frame: up to week 5 ]
  7. Anxiety by State-Trait Anxiety Inventory [ Time Frame: up to week 5 ]
  8. Frequency of adverse events [ Time Frame: up to week 5 ]
  9. Global clinical impression on insomnia by short questionnaire [ Time Frame: up to week 5 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183714    
Other Study ID Numbers: 582.1
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Sleep Initiation and Maintenance Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic