Status:
UNKNOWN
"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
Lead Sponsor:
You First Services
Conditions:
Dry Mouth
Xerostomia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, c...
Eligibility Criteria
Inclusion
- Patient should be above 18 years of age.
- Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
- Ability to attend visits at the research site
- Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
- Have a negative history of radiation therapy to head and neck
- Agree to abstain from the use of any products for xerostomia other than those provided in the study.
- Agree to comply with the conditions and schedule of the study.
Exclusion
- Subjects with open mouth sores at study entry.
- Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
- Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
- Subjects currently on medication or treatment for dry mouth/xerostomia
- Subjects \< 18 years of age
- Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
- Subjects with soft or hard tissue tumor of the oral cavity.
- Presence of severe gingivitis
- Chronic disease with concomitant oral manifestations other than xerostomia
- Subjects with conditions the investigator may feel will interfere with the condition under study.
Key Trial Info
Start Date :
August 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03295019
Start Date
August 4 2017
End Date
July 31 2019
Last Update
January 9 2019
Active Locations (1)
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1
VA WNY Healthcare System
Buffalo, New York, United States, 14215