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.
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
This study's planned enrollment of 45 is close to the median of 44 across 235 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →You First Services is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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