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

Sponsor
Italfarmaco (Industry)
Overall Status
Completed
CT.gov ID
NCT04245761
Collaborator
Opera CRO, a TIGERMED Group Company (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Sonidor®
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pilot, open, non-comparative, multicenter studyPilot, open, non-comparative, multicenter study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 27, 2018
Actual Primary Completion Date :
May 24, 2019
Actual Study Completion Date :
May 24, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pre-sleep arousal scale (PSAS); [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

Secondary Outcome Measures

  1. Insomnia Severity Index (ISI) [30 days]

    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)

  2. Patient Health Questionnaire QoL (PHQ-9) [30 days]

    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)

  3. Cognitive subscale of Pre-sleep arousal scale (PSAS) [30 days]

    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)

  4. Somatic subscale of PSAS (Pre-sleep arousal scale) [30 days]

    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)

  5. Global Assessment of Safety [30 days]

    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.

  6. Restorative Sleep Questionnaire-Daily (RSQ-D) [30 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  1. 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fizio Center Timişoara Timis Romania

Sponsors and Collaborators

  • Italfarmaco
  • Opera CRO, a TIGERMED Group Company

Investigators

  • Principal Investigator: Cecilia Turcu, Fizio Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Italfarmaco
ClinicalTrials.gov Identifier:
NCT04245761
Other Study ID Numbers:
  • DMS/18/SON/01
First Posted:
Jan 29, 2020
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021