"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

NCT03295019 | Unknown DMC FDA Device

• 1 other identifier: LUA-102-16
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test Oral Spray

EXPERIMENTAL

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.

Device: Test Oral Spray

Placebo Oral Spray

PLACEBO COMPARATOR

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.

Device: Placebo Oral Spray

Interventions

Test Oral Spray DEVICE

HA formulation of FDA listed ingredients

Test Oral Spray

Placebo Oral Spray DEVICE

Placebo formulation without the active ingredients

Placebo Oral Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• You First Services: lead

Study Sites (1)

VA WNY Healthcare System

Buffalo, New York, 14215, United States

RECRUITING

MeSH Terms

Conditions

Xerostomia; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 27, 2017
• Study Start: August 4, 2017
• Primary Completion: June 30, 2019
• Study Completion: July 31, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

US (1)