"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Dry Mouth, Xerostomia, OSA, Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT03295019
- Run by
- You First Services
- People needed
- 45
- Starts
- 2017-08-04
- Expected to finish
- 2019-07-31
- Last updated by the study team
- 2019-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA WNY Healthcare System — Buffalo, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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