"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

Sleep Apnea Clinical Trial

Official title:

Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295019
• Other study ID #: LUA-102-16
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: January 2019
• Source: You First Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Dry Mouth
• OSA
• Sleep Apnea
• Sleep Apnea Syndromes
• Xerostomia

Intervention

Device:
• Test Oral Spray
HA formulation of FDA listed ingredients
• Placebo Oral Spray
Placebo formulation without the active ingredients

Locations

Country	Name	City	State
United States	VA WNY Healthcare System	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
You First Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief from dry mouth survey using questionnaires.	Evaluate patients' perception of efficacy of a new mouth spray compared to a placebo in reducing the symptoms of dry mouth in Sleep Apnea patients. Survey will be done by distributing diaries with daily, weekly and end of study questionnaires.	9 weeks