"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

You First Services

Status: Unknown

Conditions: Xerostomia; Sleep Apnea; Dry Mouth; OSA

Treatments: Device: Test Oral Spray; Device: Placebo Oral Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT03295019

LUA-102-16

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Test Oral Spray

Experimental group

Description:

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.

Treatment:

Device: Test Oral Spray

Placebo Oral Spray

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo Oral Spray