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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks
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Study Summary
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.
Eligible Conditions
- Xerostomia
- Dry Mouth
- Obstructive Sleep Apnea
- Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relief from dry mouth survey using questionnaires.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test Oral SprayExperimental Treatment1 Intervention
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.
Group II: Placebo Oral SprayPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
You First ServicesLead Sponsor
4 Previous Clinical Trials
170 Total Patients Enrolled
2 Trials studying Xerostomia
56 Patients Enrolled for Xerostomia
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