NCT03458507 - 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)

Bakker JP, Neill AM, Campbell AJ
Nasal versus oronasal continuous positive airway pressure masks for obstructive sleep apnea: a pilot investigation of pressure requirement, residual disease, and leak. Sleep Breath. 2012 Sep;16(3):709-16. doi: 10.1007/s11325-011-0564-3. Epub 2011 Jul 29.
Borel JC, Gakwaya S, Masse JF, Melo-Silva CA, Sériès F
Impact of CPAP interface and mandibular advancement device on upper airway mechanical properties assessed with phrenic nerve stimulation in sleep apnea patients. Respir Physiol Neurobiol. 2012 Aug 15;183(2):170-6. doi: 10.1016/j.resp.2012.06.018. Epub 2012 Jul 3.
Borel JC, Tamisier R, Dias-Domingos S, Sapene M, Martin F, Stach B, Grillet Y, Muir JF, Levy P, Series F, Pepin JL; Scientific Council of The Sleep Registry of the French Federation of Pneumology (OSFP)
Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One. 2013 May 15;8(5):e64382. doi: 10.1371/journal.pone.0064382. Print 2013.
Fleck RJ Jr, Mahmoud M, McConnell K, Shott SR, Gutmark E, Amin RS
An adverse effect of positive airway pressure on the upper airway documented with magnetic resonance imaging. JAMA Otolaryngol Head Neck Surg. 2013 Jun;139(6):636-8. doi: 10.1001/jamaoto.2013.3279.
Vrijsen B, Buyse B, Belge C, Testelmans D
Upper airway obstruction during noninvasive ventilation induced by the use of an oronasal mask. J Clin Sleep Med. 2014 Sep 15;10(9):1033-5. doi: 10.5664/jcsm.4046.
Willson GN, Piper AJ, Norman M, Chaseling WG, Milross MA, Collins ER, Grunstein RR
Nasal versus full face mask for noninvasive ventilation in chronic respiratory failure. Eur Respir J. 2004 Apr;23(4):605-9.

Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation: a Randomized Crossover Trial

Details for clinical trial NCT03458507

Clinical trial NCT03458507 - References