"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

NCT ID: NCT03295019

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-04
• Study Completion Date: 2019-07-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Test Oral Spray

Intervention Type: DEVICE

HA formulation of FDA listed ingredients

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Spray

Intervention Type: DEVICE

Placebo formulation without the active ingredients

Interventions

Test Oral Spray

HA formulation of FDA listed ingredients

Intervention Type: DEVICE

Placebo Oral Spray

Placebo formulation without the active ingredients

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

You First Services

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VA WNY Healthcare System

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Archana Mishra, MD

Role: primary

Archana.Mishra@va.gov

716-834-9200

Other Identifiers

LUA-102-16

Identifier Type: -

Identifier Source: org_study_id