Sleep DisorderNCT04245761

Open Non-Comparative Study To Evaluate Administration Of a New Nutraceutical

A study testing Sonidor® in people with Sleep Disorder, run by Italfarmaco at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The Research Hypothesis for the present pilot study in a special care setting is that in a population suffering of mild and recent sleep disorders the pre-sleep arousal measured by the Pre-Sleep Arousal Scale (PSAS) after 30 days of oral administration with a nutraceutical composed of hawthorn, lavender and hop… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Sleep Disorder
What is being tested?: Sonidor®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteRomania
Study dates: 27 Dec 2018to 24 May 2019
Phase: Interventional
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women, aged 18 to 70 years with persistent, recent (at least 1 month) and mild sleep disorders related to pre-sleep arousal and reduced quality of sleeping;
PSAS at baseline between 16 and 24;
ISI at baseline ≥ 12;
Able to communicate adequately with the Investigator and to comply with the requirements for the entire study;
Capable of and freely willing to provide written informed consent prior to participating in the study;

Who cannot join

Subjects with Morningness-Eveningness Questionnaire Self-Assessment (MEQSA) values between 16 and 41; 2. Pregnancy and/or breast-feeding; 3. Subjects assuming beta blockers, hypnotic or sedative drugs or other nutraceuticals; 4. Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt, or suicidal ideation, or any other psychiatric illness (with the exception of intermittent anxiety); 5. Known intolerance to the tested product or at one of the ingredients (hawthorn, lavender or hop); 6. Drug or alcohol abuse within 12 months of Day 0; 7. All clinical conditions that, at the evaluation of the Investigator, can be referred to as secondary insomnia; 8. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days; 9. Presence of any clinically significant medical condition judged by the investigator to preclude the subject's inclusion in the study;

Trial locations and contacts

1 site in 1 country.

Romania1 site

Fizio Center
Timișoara, Timiș County

Other trials in Romania

About this study

Official title: Pilot Open Non-Comparative Study To Evaluate In Special Care Setting The Administration Of A New Nutraceutical Associated With Sleep Hygiene Guidelines In Subjects Affected By Persistent Mild Sleep Disorders

Read the detailed description

Sonidor® was developed as a nutraceutical composed of hawthorn, lavender and hop inducing sleep and relaxation in subjects with mild sleep disturbances. In addition, the Sonidor® innovative three-layer-tablet formulation should allow the active components to be released with different speeds into the gastrointestinal tract exerting a synergistic action to induce sleep-promoting effects.

Primary objective is to have a preliminary evaluation of the efficacy of Sonidor® in subjects affected by persistent mild sleep disorders (difficulty in initiating sleep for at least 1 month and reduced quality of sleeping) to whom in special care setting have been suggested sleep hygiene guidelines and administered the tested nutraceutical for one month.

Conditions: Sleep Disorder
Being tested: Sonidor®
Medical subject headings: Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sonidor®Dietary supplement
Sonidor® triple layer release tablets are developed with a specialized process to improve stability and bioavailability of the formulation based on hawthorn, lavender and hop extracts. The hawthorn, lavender and hop extracts used to product Sonidor® have an elevated content of vitexin (3%), monoterpens (4% as linalool) and flavonoids (4%), respectively.

Study groups in NCT04245761
Study group	Role	What they receive
Sonidor®	Experimental	Application: following the summary of product characteristics (l tablet per day) At the 7-day phone call the Investigator can increase the dosage to 2 tablets per day only in non-responding subjects. Receives: Dietary Supplement: Sonidor®

What is being measured

The primary outcome is the main question the study is designed to answer.

Pre-sleep arousal scale (PSAS);
Change in Pre-sleep arousal scale PSAS from a maxim of 24 to a minimum of 16 is a positive outcome for the investigational product
Measured: 30 days

Secondary outcomes (6)

Insomnia Severity Index (ISI)
Minimal score for ISI scale is 0 to 7 (clinical insignificant insomnia), 8 to 14 (bellow average insomnia), 15 to 21 (moderate insomnia) and 22 to 28 (severe insomnia)
Measured: 30 days
Patient Health Questionnaire QoL (PHQ-9)
The minimal score of this questionnaire is 0 (patient is not affected by insomnia) and the maximum score is 27 ( patient is highly affected by insomnia)
Measured: 30 days
Cognitive subscale of Pre-sleep arousal scale (PSAS)
The minimal score of this questionnaire is 0 (patient is not affected by insomnia) and the maximum score is 27 ( patient is highly affected by insomnia)
Measured: 30 days
Somatic subscale of PSAS (Pre-sleep arousal scale)
The minimal score of this questionnaire is 0 (patient is not affected by insomnia) and the maximum score is 27 ( patient is highly affected by insomnia)
Measured: 30 days
Global Assessment of Safety
it will be reported by the subject using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. Global Assessment of Safety will be evaluated at the last visit.
Measured: 30 days
Restorative Sleep Questionnaire-Daily (RSQ-D)
Provides a valid and reliable measure for assessing nonrestorative sleep complaints. It includes 9 self-report items related to various aspects of the restorative quality of sleep. The paper printed questionnaire will be completed on a daily basis by subject upon awakening. Minimum score is 0 and maximum is 100. The higher the score, the better the sleep quality
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 201824 May 2019

First posted29 Jan 2020
Study start27 Dec 2018
Primary completion24 May 2019
Study completion24 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep DisorderStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Pilot, open, non-comparative, multicenter study
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04245761
Sponsor's protocol ID: DMS/18/SON/01
Status last verified: Sep 2021
First submitted: 27 Jan 2020
Last updated: 10 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Open Non-Comparative Study To Evaluate In Special Care Setting The Administration Of A New Nutraceutical Associated With Sleep Hygiene Guidelines In Subjects Affected By Persistent Mild Sleep Disorders
ClinicalTrials.gov ID: NCT04245761
Acronym / sponsor ID: DMS/18/SON/01
Conditions: Sleep Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: ItalfarmacoIndustry (pharma, biotech, devices)
Collaborators: Opera CRO, a TIGERMED Group Company
Study start: 27 Dec 2018 (actual)
Primary completion: 24 May 2019 (actual)
Study completion: 24 May 2019 (actual)
First posted: 29 Jan 2020 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Pilot, open, non-comparative, multicenter study

Arm	Type	Receives
Sonidor®	Experimental	Dietary Supplement: Sonidor®Application: following the summary of product characteristics (l tablet per day) At the 7-day phone call the Investigator can increase the dosage to 2 tablets per day only in non-responding subjects.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Men and women, aged 18 to 70 years with persistent, recent (at least 1 month) and mild sleep disorders related to pre-sleep arousal and reduced quality of sleeping;
PSAS at baseline between 16 and 24;
ISI at baseline ≥ 12;
Able to communicate adequately with the Investigator and to comply with the requirements for the entire study;
Capable of and freely willing to provide written informed consent prior to participating in the study;

Key exclusion criteria (1 listed)

Subjects with Morningness-Eveningness Questionnaire Self-Assessment (MEQSA) values between 16 and 41; 2. Pregnancy and/or breast-feeding; 3. Subjects assuming beta blockers, hypnotic or sedative drugs or other nutraceuticals; 4. Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt, or suicidal ideation, or any other psychiatric illness (with the exception of intermittent anxiety); 5. Known intolerance to the tested product or at one of the ingredients (hawthorn, lavender or hop); 6. Drug or alcohol abuse within 12 months of Day 0; 7. All clinical conditions that, at the evaluation of the Investigator, can be referred to as secondary insomnia; 8. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days; 9. Presence of any clinically significant medical condition judged by the investigator to preclude the subject's inclusion in the study;

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
Sonidor®Sonidor® triple layer release tablets are developed with a specialized process to improve stability and bioavailability of the formulation based on hawthorn, lavender and hop extracts. The hawthorn, lavender and hop extracts used to product Sonidor® have an elevated content of vitexin (3%), monoterpens (4% as linalool) and flavonoids (4%), respectively.	Dietary supplement	Sonidor®

Primary outcome

Pre-sleep arousal scale (PSAS);
Time frame: 30 days
Change in Pre-sleep arousal scale PSAS from a maxim of 24 to a minimum of 16 is a positive outcome for the investigational product

6 secondary outcomes

Insomnia Severity Index (ISI)
Time frame: 30 days
Patient Health Questionnaire QoL (PHQ-9)
Time frame: 30 days
Cognitive subscale of Pre-sleep arousal scale (PSAS)
Time frame: 30 days
Somatic subscale of PSAS (Pre-sleep arousal scale)
Time frame: 30 days
Global Assessment of Safety
Time frame: 30 days
Restorative Sleep Questionnaire-Daily (RSQ-D)
Time frame: 30 days

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 10 Sep 2021.
Individual participant dataSharing planned: No

Related trials for Sleep Disorder

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Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
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PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruiting
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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.

Cecilia Turcu principal investigator

Fizio Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sonidor® in people with Sleep Disorder, run by Italfarmaco at 1 site in Romania.

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 1 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Pre-sleep arousal scale (PSAS); (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04245761.

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 10 Sep 2021.