Tatiana Mesquita1, Acary Souza Bulle1, Marcia Pradella-Hallinan2, Gustavo Antonio Moreira2, Carlos Arthur Freitas3, Cicília Yuko Wada4, Roberta P. Simões5, Conceição Acceturi6.
1Neuromuscular Diseases Sector, UNIFESP – Federal University of São Paulo – EPM; 2 Sleep Institute; 3 ProSearch Clinical Research; 4 Statpharm Scientific Advisory; 5 Invel®; 6 Invitare Clinical Research.
Post-Polio Syndrome (PPS) refers to new neuromuscular symptoms occurring at least 15 years after stability in patients with previous acute paralytic poliomyelitis. Among the clinical manifestations of PPS stand out muscular weakness, new atrophy in the limbs, bulbar muscles or breathing, excessive fatigue, pain, decreased physical endurance, cold intolerance and sleep disorders. (1,2,3)
Since this population characterized by the movement of increasing periodic leg (PLM), obstructive sleep apnea (OSA) and insomnia, It was proposed in this study, use of Invel® Recharge to verify the benefits of far infrared rays in these patients population with serious consequences.
If the product showed effectiveness and safety with this particular group, it would also be effective for normal individuals which, routinely, by everyday life, stress and bad habits are affected by disorders and sleep disorders.
Primary: evaluate if four weeks of Invel® Recharge usage over the mattress improved sleep quality and decreased the frequency periodic leg movement (PLM) in patients with syndrome Post-Polio. Secondary: evaluate, after 4 weeks of usage of the product made with Invel® Technology fabric on the mattress, the evolution of: Pain; daytime sleepiness; activities of daily living; quality of life and assess the safety in use of the product.
Eligible patients were female and male, between 20 and 60 years old. They were diagnosed with post-polio syndrome (PPS) according to the diagnostic criteria of the International Conference SPP 2001, whose diagnosis of PPS has been carried out between January 2003 and June 2008.
This was a prospective, randomized, controlled and blinded study. The evaluations were performed pre-treatment, after 2 weeks of usage of the material and after four weeks of treatment.
A total of 56 patients included in the study, divided into two-arm study: – ARM B: used Invel® Recharge, made with BioCeramics MIG3 Invel® fabric – Jacquard (65% polyester and 35% Polypropylene).
– ARM P: used fabric in 100% cotton without the incorporation of Biocerâmica® MIG3® Invel®. Throughout the study the patients continued to pursue their medical treatment without changing any previous procedure.
Clinical evaluations performed according to criteria and behaviors, following the visits described in the protocol previously approved by the Ethics Committee of UNIFESP / EPM were:
– Evaluation Protocol (anamnesis and general physical examination);
– Prior polysomnography examination, and at the end; Questionnaires: (pre- and post-treatment);
– Visual analogue scale of pain – VASP;
– McGill pain;
– Epworth Sleepiness;
– All-night polysomnography test;
– Daily life activities / Barthel Index;
– Quality of Life – WHOQOL-BREF.
All data were collected, stored and audited by monitoring periodically performed, and later, statistically analyzed by center certified by ANVISA. This study was properly notified to ANVISA as Resolution RDC No. 39/08.
No adverse event was observed in the studied population.
There was a statistically significant difference (p = 0.003) between groups to the decrease the latency to sleep onset on group B, which make use of the product with Invel® Technology in V2. Since the product was shown to improve sleep latency and consequently the quality of sleep in patients with PPS, we can conclude that the Invel® Recharge, made with Bioceramic® MIG3® Invel® fabric, registration ANVISA / MS Reg. No. 80104760015, could be indicated for treating sleep disorders. The product did not cause irritation and / or sensitization on research subjects, which shows that it is safe for use under the conditions in which it was tested. THE ANVISA, the National Health Surveillance Agency, recognized the effectiveness, safety and quality of this product in the therapeutic indications for treatment of subjective insomnia, decreased latency to sleep onset and RLS- restless legs syndrome, granting 24.02.2014 in the Signup Invel® Recharge ANVISA / MS Reg. No. 80104760013.
Engel AG, Armstrong CF. Myology. 2ed. New York: Mcgraw Hill Book Company; 1994. 1937p. Dubovitz V. Muscle disorders. 2ed. London: Sounders Company; 1995. 540p. Dalakas MC. Post-polio syndrome 12 years later. How it all started. Ann N Y Acad of Sci. 1995;753:11-8. Halstead LS, Rossi CD. Post-polio syndrome: clinical experience with 132 consecutive outpatients. Birth Defects Orig Artic Ser.1987;23(4):13-26.
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