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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Oral Spray | Experimental | 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. |
|
| Placebo Oral Spray | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Oral Spray | Device | HA formulation of FDA listed ingredients |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA WNY Healthcare System | Recruiting | Buffalo | New York | 14215 | United States |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001049 | Apnea |
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| Placebo Oral Spray |
| Device |
Placebo formulation without the active ingredients |
|
| D012120 |
| Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |