Back to results"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
Primary Purpose
Dry Mouth, Xerostomia, OSA
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test Oral Spray
Placebo Oral Spray
Sponsored by
About this trial
This is an interventional treatment trial for Dry Mouth
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- VA WNY Healthcare SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test Oral Spray
Placebo Oral Spray
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03295019
Brief Title
"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
Official Title
Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
You First Services
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Mouth, Xerostomia, OSA, Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Oral Spray
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Oral Spray
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Test Oral Spray
Intervention Description
HA formulation of FDA listed ingredients
Intervention Type
Device
Intervention Name(s)
Placebo Oral Spray
Intervention Description
Placebo formulation without the active ingredients
Primary Outcome Measure Information:
Title
Relief from dry mouth survey using questionnaires.
Description
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.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
VA WNY Healthcare System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Archana Mishra, MD
Phone
716-834-9200
Email
Archana.Mishra@va.gov
12. IPD Sharing Statement
Learn more about this trial
"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
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