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

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Songha Night ®

Placebo

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Songha Night ®

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in sleep quality on a 100 mm visual analogue scale (VAS)

Secondary Outcome Measures

Feeling refreshed score (six point rating scale)

Ability to concentrate and perform well score (six point rating scale)

Night-time total sleeping time

Difficulty in falling asleep (five point rating scale)

Number of awakenings during the night

Physical and mental health state by short form (SF-36) questionnaire

Anxiety by State-Trait Anxiety Inventory

Frequency of adverse events

Global clinical impression on insomnia by short questionnaire

Full Information

NCT ID

NCT02183714

First Posted

July 7, 2014

Last Updated

July 7, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02183714

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

May 1998 (undefined)

Primary Completion Date

December 1998 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Initiation and Maintenance Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

146 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Songha Night ®

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Songha Night ®

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Feeling refreshed score (six point rating scale)

Time Frame

up to week 5

Title

Ability to concentrate and perform well score (six point rating scale)

Time Frame

up to week 5

Title

Night-time total sleeping time

Time Frame

up to week 5

Title

Difficulty in falling asleep (five point rating scale)

Time Frame

up to week 5

Title

Number of awakenings during the night

Time Frame

up to week 5

Title

Physical and mental health state by short form (SF-36) questionnaire

Time Frame

up to week 5

Title

Anxiety by State-Trait Anxiety Inventory

Time Frame

up to week 5

Title

Frequency of adverse events

Time Frame

up to week 5

Title

Global clinical impression on insomnia by short questionnaire

Time Frame

up to week 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/582/582.1_U00-0003.pdf

Description

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

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