An interventional study of Test Oral Spray and Placebo Oral Spray in Dry Mouth, Xerostomia and OSA, sponsored by You First Services. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by You First Services · Not applicable, Interventional, and Treatment
During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.
Exclusion Criteria:
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Device: Test Oral Spray
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their placebo mouth spray, 2 times daily (morning and evening), for the 4 week duration of the study.
Device: Placebo Oral Spray
HA formulation of FDA listed ingredients
Placebo formulation without the active ingredients
Relief from dry mouth survey using questionnaires.
Evaluate patients' perception of efficacy of a new mouth spray compared to a placebo in reducing the symptoms of dry mouth in Sleep Apnea patients. Survey will be done by distributing diaries with daily, weekly and end of study questionnaires.
Time frame: 9 weeks
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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You First Services