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"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

NCT03295019 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-01-09

No results posted yet for this study

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

Interventions

DEVICE

Test Oral Spray

HA formulation of FDA listed ingredients

DEVICE

Placebo Oral Spray

Placebo formulation without the active ingredients

Sponsors & Collaborators

  • You First Services

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-04
Primary Completion
2019-06-30
Completion
2019-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03295019 on ClinicalTrials.gov