Open Non-Comparative Study To Evaluate Administration Of a New Nutraceutical
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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)
- 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)
- 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)
- 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)
- 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.
- 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
Inclusion Criteria:
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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;
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PSAS at baseline between 16 and 24;
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ISI at baseline ≥ 12;
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Able to communicate adequately with the Investigator and to comply with the requirements for the entire study;
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Capable of and freely willing to provide written informed consent prior to participating in the study;
Exclusion Criteria:
- 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 | |
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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.- DMS/18/SON/01