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

Primary Purpose

Sleep Disorder

Status

Completed

Phase

Not Applicable

Locations

Romania

Study Type

Interventional

Intervention

Sonidor®

About this trial

This is an interventional treatment trial for Sleep Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

l. 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;

Sites / Locations

Fizio Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sonidor®

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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)

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)

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)

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.

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

Full Information

NCT ID

NCT04245761

First Posted

January 27, 2020

Last Updated

September 2, 2021

Sponsor

Italfarmaco

Collaborators

Opera CRO, a TIGERMED Group Company

1. Study Identification

Unique Protocol Identification Number

NCT04245761

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

December 27, 2018 (Actual)

Primary Completion Date

May 24, 2019 (Actual)

Study Completion Date

May 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Italfarmaco

Collaborators

Opera CRO, a TIGERMED Group Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 (Sonidor®) shall significantly improve in comparison with the baseline condition.

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.

6. Conditions and Keywords

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

Sleep Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot, open, non-comparative, multicenter study

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sonidor®

Arm Type

Experimental

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Sonidor®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pre-sleep arousal scale (PSAS);

Description

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

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Insomnia Severity Index (ISI)

Description

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)

Time Frame

30 days

Title

Patient Health Questionnaire QoL (PHQ-9)

Description

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)

Time Frame

30 days

Title

Cognitive subscale of Pre-sleep arousal scale (PSAS)

Description

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)

Time Frame

30 days

Title

Somatic subscale of PSAS (Pre-sleep arousal scale)

Description

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)

Time Frame

30 days

Title

Global Assessment of Safety

Description

Time Frame

30 days

Title

Restorative Sleep Questionnaire-Daily (RSQ-D)

Description

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: l. 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cecilia Turcu

Organizational Affiliation

Fizio Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fizio Center

City

Timişoara

State/Province

Timis

Country

Romania

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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