NCT04607343 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Caples SM, Gami AS, Somers VK
Obstructive sleep apnea. Ann Intern Med. 2005 Feb 1;142(3):187-97. Review.
Gallas S, Marie JP, Leroi AM, Verin E
Sensory transcutaneous electrical stimulation improves post-stroke dysphagic patients. Dysphagia. 2010 Dec;25(4):291-7. doi: 10.1007/s00455-009-9259-3. Epub 2009 Oct 24.
Gillick BT, Zirpel L
Neuroplasticity: an appreciation from synapse to system. Arch Phys Med Rehabil. 2012 Oct;93(10):1846-55. doi: 10.1016/j.apmr.2012.04.026. Epub 2012 May 18. Review.
Guilleminault C, Hill MW, Simmons FB, Dement WC
Obstructive sleep apnea: electromyographic and fiberoptic studies. Exp Neurol. 1978 Oct;62(1):48-67.
Howlett OA, Lannin NA, Ada L, McKinstry C
Functional electrical stimulation improves activity after stroke: a systematic review with meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):934-43. doi: 10.1016/j.apmr.2015.01.013. Epub 2015 Jan 26. Review.
Kezirian EJ, Boudewyns A, Eisele DW, Schwartz AR, Smith PL, Van de Heyning PH, De Backer WA
Electrical stimulation of the hypoglossal nerve in the treatment of obstructive sleep apnea. Sleep Med Rev. 2010 Oct;14(5):299-305. doi: 10.1016/j.smrv.2009.10.009. Epub 2010 Jan 29. Review.
Page SJ, Cunningham DA, Plow E, Blazak B
It takes two: noninvasive brain stimulation combined with neurorehabilitation. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S89-93. doi: 10.1016/j.apmr.2014.09.019.
Schulte W, Scholze H, Werries E
Specificity of a cysteine proteinase of Entamoeba histolytica towards the alpha 1-CB2 peptide of bovine collagen type I. Mol Biochem Parasitol. 1987 Aug;25(1):39-43.

Clinical Trial of a Rehabilitation Device Based on Electrical Stimulation for Patients With Obstructive Sleep Apnoea (OSA): a Study Protocol

Details for clinical trial NCT04607343

Clinical trial NCT04607343 - References