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OpenTrials
Completed

NCT Number: NCT02183714

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.

Completed

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Songha Night ®

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
1998
Primary completion
1998
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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