Mitelos announces the results of the clinical study conducted with VIGISLEEP

Barcelona, October 20th, 2014.- Mitelos has announced the results of the clinical study conducted with its nutraceutical VIGISLEEP®. 

VIGISLEEP® is a biphasic product specially designed for the management of sleep disorders associated with circadian rhythm disturbances, changes in shift work, jet-lag, as a result of dyssynchrony between the internal clock and the external light-dark cycle.

According to statistics from Europe, USA and developing countries, up to 20% of employees work in rotating shifts. The most problematic symptoms include difficulty falling asleep, early wake-up, impaired quality of sleep between shifts and sleepiness during working hours.

The study, which lasted two months, measured the effectiveness of the product with the ISI test (Insomnia Severity Index), internationally validated. Measures were taken at days 1, 30 and 60, showing a statistically significant reduction between days 1 and 30 of the study and between days 1 and 60.

The results of the different symptoms measured to calculate the ISI index showed a decrease in the difficulty to fall asleep and to stay asleep. It was also observed a decrease in the interference with the functions during the day. The results show that the treatment has a positive effect on sleep quality, and suggest that it has a significant impact on quality of life.

No significant adverse reactions were observed. 

  • The product was recently approved in the EU
  • Mitelos has entered into negotiations with companies in several countries to grant the distribution rights

 

About Mitelos

Mitelos is a private and independent pharmaceutical company based in Barcelona that develops, registers and licenses its own nutraceuticals and health products and offers business development consulting services for third parties.

For more information, contact:

Joaquim Colomé; tel: +34 937 063 611

jcolome@mitelos.com