The Ability of Songha Night ® to Improve Sleep in Patient... | NCT02183714

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

NCT02183714

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 8, 2014Estimated

Enrollment

146Actual

Phase

Phase 3

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Songha Night ®
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1998

Primary Completion Date

Dec 1998Actual

Completion Date

Not provided

First Submitted Date

Jul 7, 2014

First Submission Date that Met QC Criteria

Jul 7, 2014

First Posted Date

Jul 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2014

Last Update Posted Date

Jul 8, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146Actual

Label	Type	Description	Intervention Names
Songha Night ®	Experimental		Drug: Songha Night ®
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Songha Night ®	Drug		Songha Night ®
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Feeling refreshed score (six point rating scale)		up to week 5
Ability to concentrate and perform well score (six point rating scale)		up to week 5
Night-time total sleeping time

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided