Sleep Initiation and Maintenance DisordersPhase 3NCT02183714
The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances
A Phase 3 study testing Songha Night ® in people with Sleep Initiation and Maintenance Disorders, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Songha Night ®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- May 1998to Dec 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.
- Being tested
- Songha Night ®, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Songha Night ®Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Songha Night ® | Experimental | Not described Receives: Drug: Songha Night ® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quality on a 100 mm visual analogue scale (VAS)
Measured: baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment
Secondary outcomes (9)
Feeling refreshed score (six point rating scale)
Measured: up to week 5
Ability to concentrate and perform well score (six point rating scale)
Measured: up to week 5
Night-time total sleeping time
Measured: up to week 5
Difficulty in falling asleep (five point rating scale)
Measured: up to week 5
Number of awakenings during the night
Measured: up to week 5
Physical and mental health state by short form (SF-36) questionnaire
Measured: up to week 5
Anxiety by State-Trait Anxiety Inventory
Measured: up to week 5
Frequency of adverse events
Measured: up to week 5
Global clinical impression on insomnia by short questionnaire
Measured: up to week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 1998
- Primary completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183714
- Sponsor's protocol ID
- 582.1
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances
- ClinicalTrials.gov ID
- NCT02183714
- Acronym / sponsor ID
- 582.1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Songha Night ® | Experimental | Drug: Songha Night ® |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Songha Night ® | Drug | Songha Night ® |
| Placebo | Drug | Placebo |
Primary outcome
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
9 secondary outcomes
Feeling refreshed score (six point rating scale)
Time frame: up to week 5
Ability to concentrate and perform well score (six point rating scale)
Time frame: up to week 5
Night-time total sleeping time
Time frame: up to week 5
Difficulty in falling asleep (five point rating scale)
Time frame: up to week 5
Number of awakenings during the night
Time frame: up to week 5
Physical and mental health state by short form (SF-36) questionnaire
Time frame: up to week 5
Anxiety by State-Trait Anxiety Inventory
Time frame: up to week 5
Frequency of adverse events
Time frame: up to week 5
Global clinical impression on insomnia by short questionnaire
Time frame: up to week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Songha Night ® in people with Sleep Initiation and Maintenance Disorders, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.