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

NCT04245761 | Completed

• 1 other identifier: DMS/18/SON/01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Insomnia Severity Index (ISI)

  30 days

• Patient Health Questionnaire QoL (PHQ-9)

  30 days

• Cognitive subscale of Pre-sleep arousal scale (PSAS)

  30 days

• Somatic subscale of PSAS (Pre-sleep arousal scale)

  30 days

• Global Assessment of Safety

  30 days

Study Arms (1)

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.

Dietary Supplement: Sonidor®

Interventions

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.

Sonidor®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

Sponsors & Collaborators

• Italfarmaco: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Fizio Center

Timișoara, Timiș County, Romania

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Cecilia Turcu

  Fizio Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot, open, non-comparative, multicenter study

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: December 27, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)