"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03295019|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dry Mouth Xerostomia OSA Sleep Apnea||Device: Test Oral Spray Device: Placebo Oral Spray||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.|
|Actual Study Start Date :||August 4, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: 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.
Device: Test Oral Spray
HA formulation of FDA listed ingredients
Placebo Comparator: 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.
Device: Placebo Oral Spray
Placebo formulation without the active ingredients
- Relief from dry mouth survey using questionnaires. [ Time Frame: 9 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295019
|United States, New York|
|VA WNY Healthcare System||Recruiting|
|Buffalo, New York, United States, 14215|
|Contact: Archana Mishra, MD 716-834-9200 Archana.Mishra@va.gov|