Recruiting

Hyaluronan

Sponsor:

You First Services

Code:

NCT03295019

Conditions

Dry Mouth

Xerostomia

OSA

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Test Oral Spray

Placebo Oral Spray

Study Details

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, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.

Conditions

Dry Mouth

Xerostomia

OSA

Sleep Apnea

Study ID

NCT03295019

Start date

Aug 4, 2017

Status verified date

Jan, 2019

Completion date

Jul 31, 2019

Anticipated

Primary completion date

Jun 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient should be above 18 years of age.
2. 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.
3. Ability to attend visits at the research site
4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
5. Have a negative history of radiation therapy to head and neck
6. Agree to abstain from the use of any products for xerostomia other than those provided in the study.
7. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Subjects with open mouth sores at study entry.
2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
4. Subjects currently on medication or treatment for dry mouth/xerostomia
5. Subjects < 18 years of age
6. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
7. Subjects with soft or hard tissue tumor of the oral cavity.
8. Presence of severe gingivitis
9. Chronic disease with concomitant oral manifestations other than xerostomia
10. Subjects with conditions the investigator may feel will interfere with the condition under study.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Test Oral Spray

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 comparator: Placebo Oral Spray

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.

Interventions

Test Oral Spray

HA formulation of FDA listed ingredients

Placebo Oral Spray

Placebo formulation without the active ingredients

Primary outcome measure

  • Relief from dry mouth survey using questionnaires. [ Time Frame: 9 weeks ]

Central Contacts and Locations

Locations

VA WNY Healthcare System

Recruiting

Buffalo, New York, United States, 14215

Contacts

More Information

Sponsor

You First Services

Last update posted

Jan 9, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by You First Services on 2019-01-09.