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"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. Identifier: NCT03295019
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
You First Services

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.

Condition or disease Intervention/treatment Phase
Dry Mouth Xerostomia OSA Sleep Apnea Device: Test Oral Spray Device: Placebo Oral Spray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03295019

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United States, New York
VA WNY Healthcare System Recruiting
Buffalo, New York, United States, 14215
Contact: Archana Mishra, MD    716-834-9200   
Sponsors and Collaborators
You First Services
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Responsible Party: You First Services Identifier: NCT03295019    
Other Study ID Numbers: LUA-102-16
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases