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

Sleep Disorder Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

• NCT number: NCT04245761
• Study type: Interventional
• Source: Italfarmaco
• Status: Completed
• Phase: N/A
• Start date: December 27, 2018
• Completion date: May 24, 2019