Trials / Unknown
UnknownNCT03295019
"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- You First Services · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Test Oral Spray | HA formulation of FDA listed ingredients |
| DEVICE | Placebo Oral Spray | Placebo formulation without the active ingredients |
Timeline
- Start date
- 2017-08-04
- Primary completion
- 2019-06-30
- Completion
- 2019-07-31
- First posted
- 2017-09-27
- Last updated
- 2019-01-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03295019. Inclusion in this directory is not an endorsement.