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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder
• Intervention / Treatment: Dietary supplement: Sonidor®

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Timis
    • Timişoara, Timis, Romania
      • Fizio Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. PSAS at baseline between 16 and 24;
3. ISI at baseline ≥ 12;
4. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study;
5. 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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.	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	30 days

Collaborators and Investigators

• Sponsor: Italfarmaco
• Collaborators: Opera CRO, a TIGERMED Group Company
• Investigators: Principal Investigator: Cecilia Turcu, Fizio Center

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2018
• Primary Completion (Actual): May 24, 2019
• Study Completion (Actual): May 24, 2019

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: DMS/18/SON/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No